Tuesday, September 30, 2008

"My house is a very, very, very fine house" CSNY

Time, time time is on my side

The Rolling Stones

Well, despite Dr. Forman's OK, I have decided to avoid the several hours of recycled plane air and the 10 days of Italian culture and food. Instead I will stay home and enjoy sunny Socal. I will miss seeing my son Will and his beautiful and talented muse Laura in Florence, but they will be back home in December. No Botticelli or gelato for now. I will go when I don't have to spend so much of my time worrying about food and meds and masks and toilets and crowds. And when I can drink some vino. It will be more of a vacation. More relaxed. 

And I can wait.

Before the transplant, there was an urgency to travel, to build memories to see me through, and to give my wife and children images to counter what might be desperate times ahead. To have something fresh and positive to hold onto should the worst have happened.

But that is no longer the case. Now, "Time is on my side, Yes it is"

Thanks to all those who wrote, pro and con. It really helped me sort this out.

FYI, the John Deutschendorf referenced in my last post is probably better known to you by his stage name, John Denver.

Sunday, September 28, 2008

"Leaving on a Jet Plane" John Deutschendorf, but I first heard it by Peter, Paul and Mary

Well, maybe.

Here's a latter I wrote to the CLL and Bone marrow transplant  ACOR lists. I am asking you to also weigh in. My wife has never been to Italy. I've been twice, but never to Venice.

Dear Friends,

My mini-allo matched unrelated donor transplant for CLL took place on July 1 and I have had an extremely easy time. No graft versus host, but still a complete remission MRD neg.  I am on tacrolimus and sirolimus. The only problem is that I am only 28% donor in my blood and 56% donor in T cells. Been home for 2 months. I am thinking of visiting my son in Florence and also seeing Rome and maybe Venice in November. I hear Venice is not very clean. I will be day about day 140+

I would appreciate any warnings or advice about the sanity and safety of the trip. I am holding precious and rare tickets bought with frequent flyer miles  until  Oct 2 only.


"Happiness runs in a circular motion" Donovan

Happiness runs in a circular motion
Thought is like a little boat upon the sea.
Everybody is a part of everything anyway,
You can have everything if you let yourself be.
Happiness runs, happiness runs.


Thank you to those who worried about my mood from my last post. I am hoping the choice of these chipper lyrics from the blissed out 60's troubadour, the Sunshine Superman, the tie-dyed master of Mellow Yellow, will ease your troubled minds. The first song my wife ever sang me for me for Donovan's "Catch the Wind". 

Listen, I am not sad. Au contraire. I don't deny that I have had my moments of despair. I can't stare down the barrel of a loaded IV full of all that it possible and irreversible with out the occasional sober reflection.

But my last post was not coming from that place. It was coming from a place of hope and salvation. Now while I believe that the gates of heaven are always open, the ritual preserved in my ancestral memories, deeper than my marrow, demands that this is the season to do my work of teshuvah:
Look at the Hebrew: Teshuvah - The root word is the Hebrew "shoov" which means to return. It combines both aspects of forgiveness: turning from evil and turning toward good. The Jews make restitution during this period with those they have offended. Ridding oneself of guilt is a goal of Teshuvah. Repentance, however, only applies to transgressions committed against G-d. To receive forgiveness from offenses committed against fellow man, compensation must be made and a plea for forgiveness.

By Rabbi Yosef McBride of "Kehilat Beit Yehudah" 

This is a part of my healing myself and the world. They are linked, for sure. It is work full of joy. To quote from another tradition (Mark 8:36): What does it profit a man to gain the world and lose his soul . I am so happy to be doing this, to have this chance, and I believe that it is a necessary part of my cure.

That is what my last note was about, not about sadness and before I am rightly accused of public self-flagellation, I will desist.

May we all be inscribed in the Book of Life for the coming Year.

Friday, September 26, 2008

"We're so sorry, Uncle Albert" Paul McCartney

If I, if I have been unkind,
I hope that you can just let it go by.
If I, if I have been untrue
I hope you know it was never to you.

Leonard Cohen ( Bird on a Wire)

Please forgive me. For failing to be all I could be, for not being responsive to your calls for help, for being so focused on my struggles, I did not see yours.

Forgive me for asking for it all, and being upset when I didn't get. Forgive me, and this is big one, for not thanking you all, especially my patients and staff who have been so generous with your gifts and words of love.

Little things I should have said and done
I just never took the time
You were always on my mind
You were always on my mind

Wayne Thompson, Mark James, & Johnny Christopher

This is not a backhanded way to solicit  posts or emails trying to reassure me or cheer me up. I am not depressed, just human. This is a mitzvah, a commandment, my redemptive work in preparation for the Jewish New Year. 

I am also not blind to both my faults and my virtues. I know that the blog is a good thing and I am proud of much of what I do. But like all of us, I am flawed and have hurt others through omission and commission.

Please, please do not respond, unless there is some wrong I have done that I can undo or you can find it in your heart to forgive. Then please do send me an email (BkoffmanMD@gmail.com) and I will reply.

So many hearts I find, broke like yours and mine
Torn by what we've done and can't undo

Jennifer Warnes & Leonard Cohen (Song of Bernadette)

May we all have a year of health and joy.

G-d bless

Thursday, September 25, 2008

"Lettuce be lovers, We'll marry our fortunes together" With apologies to Simon and Garfunkel

This scene is produced with produce
(click on the picture to take a close look)

Thank you Sean for sending me the landscape in food.

Your timing was perfect because today I ate lettuce. My first taste of a fresh uncooked vegetable in over 3 months. 

It was a bite of heaven. Crisp, a bit tart and so light and alive.

I could cry with joy. 

Now of course Patty washed it first in diluted bleach and rinsed in at least 5 times, but it was still RAW.

"Well, I ain't superstitious" Willie Dixon

Willie (I am the Blues) Dixon

When you believe in things that you don't understand, 
Then you suffer, 
Superstition ain't the way

Stevie Wonder

I saw Willie Dixon in a small smokey crowded club (El Macombo) in Toronto. I still can see and hear him, that big man on that small stage, surrounded by great musicians and beautiful young groupies.

I also saw "Little" Stevie Wonder open for the Stones in Montreal at the old hockey rink, the Forum. I think it was 1970. A less intimate venue, but still great music.

The wonderful Canadian CLL website (Check out http://www.cllcanada.ca/ ) is labelled George Thorogood's "Bad to the Bone", not his cover of Booker T. Jones and William Belle's "Born Under a Bad Sign". 

Dr. Wendy Harpham, the healthy survivor, adds an extra oomph to the propitious choice of October 18 for the party. You will enjoy her article at the link below. The whole issue of luck is intriguing.

For me I like to paraphrase one of my heros, Arnold Palmer, " The more I prepare, the luckier I get"

Check out.


Wednesday, September 24, 2008

"It wouldn't be make-believe if you believe in me" Arlen and Harburg

It's a Barnum and Bailey world
Just as phony as it can be
But it wouldn't be make-believe
If you believed in me

The LA Kings are 3 and 0 but it only preseason, make-believe. Only a paper moon.

One extra I got from my young donor that's not make-believe, but painfully real every time I look in the mirror, is pimples. a few tender zits breaking out on all over my body. It was worse in July, but it is still there. The real source of course, is not youthful acne returning because of my donor's young age. Wouldn't that be great! I would so be willing to trade oily skin for a few of my other organs being as vigorous and strong and resilient as when I was 22. I was thinking of my arthritic knees, weren't you?

The real source of my bad skin is my suppressed immunity so that normal skin bacteria are now opportunists invading and inflaming my pores and hair follicles. No biggie, but just a reminder of how much easier it is to breach my natural defences of skin and mucous membranes.  Wash those hands and careful what you eat, even as restrictions are being lifted.

As my recent lighter posts reveal, I am procrastinating on facing a few big issues I need to share. I'll get there, but not yet. DLI, future monitoring, living with a different kind of uncertainty, the Jewish New Year, my son's new car (thank you Del, for the 96 Cadillac Concours), reclaiming or selling our old giant Mike Hill sculpture, re-entering the world as my immunity improves, and of course, the PARTY on OCT 18.

One excuse I will allow myself. I have been luxuriating in the emails and comments I have received from lurkers all over the planet. My world has grown by the learning of the stories of the people who have been on parts of this journey with me. My staff and patients have been particularly generous in their words. Thank you.

I have said it before. Actually Tom Robbins said it, and I just am repeating it: Everything is connected. That's the secret of life.

It's still not too late. Add a comment or email at BkoffmanMD@gmail.com I will thank you and you will feel good about it.  I promise that this is my last shameless appeal.

For now.

Tuesday, September 23, 2008

" It is never too late to start all over again" Steppenwolf

If only you believe like I believe, baby 
We'd get by 
If only you believe in miracles, baby 
So would I 

Jefferson Starship

Wow. You lurkers have been amazing. Now tell me, wasn't your fear of the email (BkoffmanMD@gmail.com) or posting a comment much worse than the act itself?

Sort of like a bone marrow transplant.

The notes you have sent have touched my heart and opened my eyes. If you haven't contacted me yet, it is not too late to start all over again. It is a win-win. I'll even write back, at least a thanks.

One more thing.

I now believe in miracles: The LA Kings won two hockey games in one night yesterday. That has never happened before. I'm talking LA Kings, the worst hockey franchise in the NHL. A real miracle.

I figure if the Kings can win with their young team of  skaters, so can I with my young team of donor T cells. Forgive me for that awkward analogy, but I am grabbing at anything out there that gives me hope.

Monday, September 22, 2008

"Please Please, Mr. Postman Wait and see Is there a letter in your bag for me" Garrett, Holland, Gorman, Dobbins, Bateman Performed by the Beatles

Deliver the letter.
Dee sooner, Dee better

I am loving the letters and post of introductions and reconnections. It helps so much to know who is reading what I am posting. Thank you. Thank you.

Now for your lurkers. That's OK.  You don't need to break your vows of silence. I understand your reticence. I too lurk around on many excellent CLL and BMT and ITP lists and blogs, zooming in to deposit a word or two only occasionally when I spot a glaring need and I have the energy to respond.

Still it would be sweet to hear from you and know a bit of why you spend some of your precious time with me.

Add a comment here or email me at bkoffmanMD@gmail.com

My clinic visit today showed stable lab. Dr. Forman said that we two will be joined at the hip for quite awhile due to my chimerism issue. That's the fact that I am still only 28-32% donor in my blood and and between 56-66% in the critical T cells. Most are close to 100% donor in both by now. The fancy tests measuring those such things are being repeated in a week with results in two. The trend is important and to have a trend you need may data points over time. This is my new challenge, but hey: Go from strength to strength as the Psalmist said.

I am presently researching DLI (donor leucocyte infusions) and will report back later this week with my findings.  I am preparing for a battle I am hoping never to fight. For those lost in my medicalese, think of a DLI as a mini-mini transplant used to boost the percent of the blood that is donor (up the chimerism) and also wipe out any residual or relapsed cancer.

If you have had a DLI or have info to share, please contact me.

Sunday, September 21, 2008

"Where are You? Adamson and McNugh (sung by Old Blue Eyes)

I never give you my number
I only give you my situation
and in the middle of investigation
I break down

The Beatles

Some time this week, this little blog of mine passed 30,000 page loads, 20,000 unique visitors, and 10,000 first time visitors. The blog has been visited by people from every continent (except Antarctica). What's wrong with you penguins? No internet? All that action with no sex or drugs, but a heavy dose of classic rock and roll.

Thank you. You have given me a sense of purpose as I push forward. I am in your debt. We are all connected.

For those have yet to contact me, please add a comment to this post or simply email at BkoffmanMD@gmail.com. Your privacy will be respected, but I do want to know who you are where you live, and what is your point of contact with my story. A patient? A friend? Family? A CLLer?  A fellow chimera?

As you have noticed, post have been more erratic recently, but there will be a small flurry of activity as I  approach day 100+ and the party to follow. Planning is ongoing.

"Don't come around here no more" Tom Petty and the Heartbreakers

I don't feel you anymore
You darken my door
Whatever you're looking for
Hey, don't come around here no more

Tom Petty and the Heartbreakers

This is similar to a letter I wrote to a CLL group about a possible reason that patients that are disease free or in CR (complete remission), for years can have a late reoccurrence:

CR, MRD (minimal residual disease) negative is great news, the best news a CLLer can get, and bodes well for the future, but it does not mean there is no cancer in our body. It does not necessarily mean disease free.

Remember that even PCR (polymerase chain reaction), the most powerful tool we have to search for our enemy, has limits in its ability to detect cancerous clonal cells. PCR may find 1 in 100,000 bad boys, but not 1 in 10,000,000. And we have billions and billions of white cells. Remember that nodes <  1 cm are considered normal but they can harbor huge numbers of cancerous cells. Remember a sample is just a sample. 

Let me use another disease as an example. I have patients who after treatment for confirmed AIDS have no detectable HIV virus in their blood, but believe me it's there. Just stop the treatment and see what happens!

Remember also the fable of the doubling of the rice grain. The Chinese emperor was so happy with the invention of the game of chess, he asked the inventor what gift he would like. He replied only that 1 grain of rice be placed on the first square of the chess board, 2 on the next and then 4, 8 16 constantly doubling until the 64th square was reached. The ruler was insulted by the meager demand, insisting that such a request did not befit an emperor. The inventor persisted asking only for the emperor's promise to comply or the throne and all it's wealth and power were his. Agreed. You know the rest of the story: 2 to the 64th power is approximately 2 followed by 19 zeros, more than the world's production of rice.

I tell this apocryphal tale to emphasize that it all starts with just one bad cell or one grain of rice, but given enough time and enough doubling, the numbers can become scary. Add to this the survival of the fittest. The few clonal cells not destroyed in the battle are the most robust, the most resistant, and are very pissed off. And their competition for space and resources has been eliminated.

I don't say this too dishearten, just to prepare. This does not mean there is no escape. Many of us will die years down the line of other cause before CLL reoccurs. For others our more healthy immune system rebuilt during a long remission or with a transplant will be constantly finding and destroying any clonal activity before it is even apparent. The price of freedom is indeed eternal vigilance.

That's my take.

Saturday, September 20, 2008

" You don't know what you got til it's gone" Joni Mitchell

I've just seen a face

The Beatles

Look, Mom. NO MASK

And just a hint of hair growing back. Same salt and pepper but curly. Peach fuzzy really. I look like a newborn: bald and wrinkled, minus the cuteness factor. Oh, yea and the mustache.

Life is surely returning to my new normal.

Friday, September 19, 2008

"I've got x-ray eyes" Kiss

I'm looking through you, where did you go 
I thought I knew you, what did I know 
You don't look different, but you have changed
I'm looking through you, you're not the same 

The Beatles

Not the same in a good way. CT scan looked through me and found me changed. There were no longer any enlarged cancerous nodes. The nodes that had measured up to a scary 5 cm. in my belly now top out at boring 8 mm. The City of Hope's GE Lightspeed scanner try as it might, couldn't find any honkin' nodes in the neck, axillae (armpits for the not medical), abdomen, or groin. 

This doesn't mean that there is no cancer. Small nodes can harbor significant collections of cancer cells. What it does mean is that there is NO EVIDENCE OF CANCER IN MY BODY. At the very worst, I am most officially in a COMPLETE REMISSION (CR, MRD or minimal residual disease negative). And that's wonderful.

At the best, it mean the C word: CURE. Now as Dr Wendy Harpham likes to point out, you don't know if you were cured until you die. If you die from some other cause, for what it was worth, it was a cure. If you're done in from a relapse, it wasn't.  Either way you have moved on, hopefully to a place where no-one has heard of cancer and nothing is ever cured cause nothing ever needs to be.  Who knows? 

Now while this earthly life only offers fake promises of certainty, if you get a full five years out with no evidence of disease, you are looking pretty fine. The Kaplan-Meier curve that predicts the chances you are going to die of the leukemia are getting darn near flat 5 years out.  That means those of us who make it to that magic five years out are not often dipping our toes back into the murky waters of leukemia. It may be true, that post transplant we have twice the chance of dying annually as the next guy, (just try and buy life insurance), those odds are actually pretty good. Even when you are 99 years old, chances are good you will live the next 365 days it take to make it to 100.

Roshi, my Zen teacher when asked about the trick to his living to a vigorous 100, said: Make it 99 and then be very careful.

So while I may not have to wait until I am dead or 100, only time will tell if my CR has become the wonderful C word: CURE.

But I am very much alive today and not waiting for confirmation to inject another C: word: CELEBRATION



Wednesday, September 17, 2008

'Life's a Beach"

It's just the way things change now like the shoreline and the sea

Leonard Cohen

Patty and I are taking a few days off the Internet to be be soothed by the lapping Pacific waves of Crystal Cove,  http://www.crystalcovebeachcottages.org/html/index.html , just 6 miles from where we live, but a quantum leap away in the diminution of distraction and the celebration  of the natural.  And the sunsets. I am thankful for every one of them. A year ago, our last visit to the Cove,  I was not so certain I had too many left. In fact, I had told Patty I wanted that particular Cohen tune " That's no way  to say goodbye" sung at my funeral. It's that old voodoo, that if you are prepared for the worst, you won't need it.

Now at day 75 post transplant, I can start to relax a bit, and go even outside (if there is no crowd) without a mask. Soon I will be eating salads again. The grim harvester also must wait and watch.

I admit that I did come home for an hour today to pick up a fax. It showed the good news that my bone marrow FISH studies are normal. That's another confirmation of no CLL in the bone marrow. CT scan is in 2 days so I am not going to spend much longer here in the digital world, when those analog beaches are beckoning.

Later, dudes

Monday, September 15, 2008

"It's still the same old story A fight for love and glory A case of do or die. " Herman Hupfeld

Play it again, Sam

My bone marrow reflected my peripheral blood: 29% donor at day 65 with 56% donor T cells. My blood at day 55 was 28% donor and 64% T cells.

I am scheduled for a CT scan on Friday and repeat chimerism studies in 2 weeks, with the results in 3. More clues, but the answer may only come when we send a trend, over time. More waiting, I am afraid.

For now, there is no change in course. Dr Forman says he will let the disease determine the next move.  Seems a touch reactive to me, but why make a risky move when we are in a bit of a fog, and the ship is doing just fine, thank you, as time goes by.

"Anticipation, anticipation Is makin' me late Is keepin' me waitin'" Carly Simon

The waiting room. Was there ever a more appropriate name!

Sitting, waiting to see Dr. Forman for more good news. Expect the best, prepare for the worst. I try to radically pare down my questions for the doc to the minimum. No what ifs. They just don't help. And they can go on endlessly, which will try the patience of the most congenial and unhurried doctor. Do those creatures exist?

More later.

Friday, September 12, 2008

"Cause it's the little things, oh, that mean a lot. It's what you are, not what you got" Sonny and Cher

Wild thing, I think you move me
But I wanna know for sure

The Troggs

4 days ago, I promised full disclosure so no later plot twist takes the luster off my great news: no CLL in my bone marrow. 

But even this gonzo reporter can't spray his words at an evanescent target.  I want to scream: Drop your weapons and come out with your hands over your head. And cough up the answers.  Is the engraftment taking? Should we speed it along? If not, why not? Am I threatening to reject this gift of a new chance because of my lack of chemo before? 

The more chemo pre-transplant, the lower the risk of graft failure. Prior chemo wallops the immune system so the body's ability to fight off anything such as an unrelated donor graft, an invasion by bacteria or virus, or a return of cancer is diminished. I had no chemo, nada, so my most unusual path to transplant puts me at an unusually high risk. And another push down that slippery slope is that my blood levels of the immunosuppressive anti-rejection medications have been at the low end of normal. So just increase the meds or add new ones, stupid and move on to happier days.
Not so fast! 

If my T cells, those generals of my immune army, are mostly donor, and they are. maybe they need the safety off their biological weapons of mass destruction, so they can wipe out those nagging old blood cells from the old me. That usually means reducing or stopping the immunosuppressive drugs.

Tricky eh? If I were my own doctor (and no snide comments please) I would do nothing until it was clear what to do: PRIMUM NON NOCERE ( Above all, Do no harm)

So how do we dig and get the answer? We need good intelligence. How do we get it? Is there a test or procedure that might help shine a light? I am still waiting to see if there are clues from the details of my last bone marrow biopsy and engraftment study.

We have taken over the enemy's capitol fortress.  No cancer to be seen. As the prez said: "Mission accomplished." Now begins the real task of holding it and rebuilding a blood system from the bottom up that is not infested with hidden terrorists waiting for a chance to emerge from the darkness when our attention is elsewhere.

I feel in my heart I have won a complete and unconditional victory, "but I wanna know for sure."

Monday, September 8, 2008

"Celebrate good times, come on! (Let's celebrate)" Cool and The Gang

I just returned from the doctor and I am bursting with the good news: No leukemia in the bone marrow. If this is not an outright cure, it is at least  a deep remission, (MRD negative by 4 color flow cytometry for the CLL savvy) a necessary and critical step in the right direction of leaving CLL disappearing in the rear view mirror.  Like my friend, Robert flooring his tricked out Porsche Carrera and saying goodbye to my beemer like it's standing still. Or that my nice sport sedan is moving in reverse. This is a true high five moment. CT scans and engraftment studies are still pending. I will write soon about what this could mean and how it fits into the whole picture, but nothing, nothing at all can take away the joy of this moment.
I am so happy.
Pardon all the adolescent car imagery. We are still looking for wheels for Ben ( email him at vincentmeloy@aol.com if you can help, please).

Sunday, September 7, 2008

" I won't back down" Tom Petty and the Heartbreakers

As someone long prepared for the occasion;
In full command of every plan you wrecked –
Do not choose a coward’s explanation
that hides behind the cause and the effect.

Leonard Cohen

Dr. Wendy Harpham, who shares the wisdom and experience that only comes from having been on both sides of the stethoscope, suggests that there are other goals beside cure. Her stance is at the same time compassionate, realistic and courageous. But I ain't hearing any of it.

I am just not ready to go there. Heck, I just played Russian roulette with a very loaded gun of a matched unrelated donor stem cell transplant. This is the real deal. The point of the whole bloody exercise is not to break even. I could do that standing still. The point is to leave CLL dying in the dust after the new imported immune SWAT team that haven't been corrupted by cancer's clonal madness, worked it over but good. No hiding in the nodes or bone marrow for a later guerrilla attack, but fully gone. Kaput. Fini. That is why I picked up that loaded pistol of someone else's stem cells. I am wiling to accept collateral damage. I am not risk adverse. The stakes are for keeps.

Tomorrow I may get a better sense of how much further I need to go if I have not already arrived. All that may be left is the mopping up. Cure is the goal. if I'm not there I will be merciless in my pursuit of any lingering leukemic cells. If you don't give up, you're never defeated.

It's been said before: The price of freedom is eternal vigilance. The new immune system doesn't sleep, but I do, so until the good news tomorrow, I remain your faithful gonzo reporter from the cancer battlefield.

Friday, September 5, 2008

"Get on down to the main attraction. With a little less talk and a lot more action." Toby Keith

I am asking for your help today.

I am thinking about attending a writers' workshop and/or classes. Been reading about writing. I am worried about talking about it too much and spending all my energy blabbing into the air, instead of into the keyboard. To the other writers (and readers) out there, I am interested in your take.

Just a quick update. Trying to keep my eye on the ball. Cure, not engraftment. I may not have the all the results of my bone marrow biopsy for my Monday appointment. Waiting again. As Wendy Harpham, MD (author of the must read: Happiness in a Storm) reminds me: the truth will set you free. I do believe that. That means my mantra of constant vigilance and hope.

Just the slightest soreness from my biopsy.  The procedure itself catches my breath when they do the actual aspiration. Stops me in mid sentence. The aspiration is worse then the grinding biopsy. It lasts only a few seconds. In fact, the whole procedure is just a few minutes and the total OUCH time is way less than a minute.

Still looking for an inexpensive car or truck for my son Ben, soon. Email me  ( BkoffmanMD@gmail.com ) or better him ( vincentmeloy@aol.com ) if you can help.

Thursday, September 4, 2008

"I want to tell you. I feel hung up and I don't know why" The Beatles

"To be or not to be isn't the question. The question is how to prolong being."

Here's a letter I just wrote to a friend, my favorite author. It provides an overview of my story June through September.

I had the bone marrow biopsy today. All I can say is OUCH! Not that bad really. Dr. Forman says the main thing he is looking for for any CLL that might be hiding in deep in the bones, not the percentage engraftment. On the way home, Patty and I walked through a surprisingly wild and woodsy trail with dappled and turtled creeks and lakes, all of this, believe it or not, in Long Beach. It is good to walk after the biopsy.  Doesn't let those needled muscles and bone stiffen up. Truth be told, it is good to walk any time. Especially in nature. Then take a long nap.

Sept. 3, 2008

Dear ----,

Much has happened since I last wrote in June about my then planned bone marrow transplant. It happened, as scheduled, July 1.

I have hesitated to contact you until I had some clarity on my progress in morphing to a chimera, on the road to a cure, but that might be a long wait.

I received my IV shot of redemption, my new immune system, in the form of stem cells packed in ice, then quickly flown by courier after being donated by a 22-year-old Israeli Yeshiva student who was a perfect 12/12 match, my biological doppelganger. My hospital course was unusually easy, and to everyone’s’ surprise and delight, I was shipped home only 3 weeks later.

I am now bald and on a most restrictive low bacteria diet. I must wear a special mask when I leave the house, but I am home with my wife and, until last week, my kids. The pets and plants are still off limits.

Not a single major complication. I just tire easily. And I fight the ennui from being stuck at home for months to come.

I am planning to write. Non-fiction. Now that’s work that makes a transplant look like a walk in the park!

The big issue is that I have been excessively slow to engraft, or have my donor cells dominate my blood and bone marrow. I am still what is medically called  “ mixed chimerism”, part donor, part old me.

T cells are the generals of the immune system that give the marching orders to the other white blood cells, the killers and the helpers of the immune system. Mine are a healthy 2/3 from my young student rabbi donor. Trouble is that the troops have been most stubborn, refusing to fall in line and my peripheral blood is only 28% donor, down from 32% last month.

This might be perfect and I may be walking a gentle and slow Buddha-like middle path that is both keeping me from the dreaded graft versus host complications and at the same time providing enough of the new immune system (my old one was corrupted by the cancer) to search out and destroy my leukemia. The best of both worlds. The holy grail of the transplant world.

But it also might mean that I am rejecting the graft and may need to start the whole process all over. That is not only trying, but risky. Tomorrow I am having a bone marrow biopsy, which might sort this out, or not. I pushed my doctor not to wait a month to literally drill for more information. The biopsy will at best relieve my false worries 3 weeks sooner or at worst, allow a prompt response to a most difficult situation, before it is a fait accompli.

I’d be lying if I said it was easy to stay both vigilant and upbeat at all time. Meditating helps. Love is the engine of change and survival, but it’s still tough.

The tests will not only determine when I can toss my mask, eat a salad (or vice versa) or go to a concert or get on a plane. They might reveal my future.

Then again, I was never promised clarity. I was only promised risks.

I wish I could have laid out for you a painted scene with wider vistas and deeper perspectives, but there will be time for that in the future. For now, my friend, I must entangle you in the details of the process.

A quick Koffman family update: Patty is playing drums in our living room; Rachael is designing low cost housing in San Francisco; Nick is hoping to circle the globe developing plans to recycle obsolete American military bases; Heather has just started her Manhattan law practice; Ben is filming a JBL/Caltech movie about radio telescopy and another about the punk scene in Santa Ana, and Will is studying art in Florence, Italy.

Be well. Stay in touch. Drop by if you venture to SoCal.


Brian Koffman


DR Castro's Study as UCSD

These looks pretty exciting. It is trying to get the immune system to wake up and attack the cancer. It you are at all interested. contact Dr Castro and his team at UCSD to get all the details.

Below if the informed consent


Intanodal ISF35  


Page 1 of 10 


University of California, San Diego 

Consent to Act as a Research Subject 








Januario E. Castro, MD and his associates are conducting a research study that uses an experimental agent called Adenovirus-ISF35 or Ad-ISF35.  Ad-ISF35 is a cold virus that has been changed in the laboratory so that it is not likely to reproduce or cause an infection once it is in your body.  Ad-ISF35 will be injected into your lymph nodes and your response to this injection will be monitored. In this case, the adenovirus is used to add a copy of ISF35 to your leukemia cells. The injection of Ad-ISF35 is considered ‘investigational’, that is, not approved by the FDA (Food and Drug Administration).  


You are being asked to take part in this study because you have chronic lymphocytic leukemia (CLL) or small cell lymphocytic leukemia (SLL) and have either been treated unsuccessfully by other standard means or have chosen not to receive chemotherapy. 


This study is being done at UCSD; approximately 23 subjects will be enrolled.   


Study Purpose 

The goal of this clinical research study is to evaluate the safety and side effects, as well as to evaluate any potential clinical and biologic response to ISF35 as used in this study.  


Study Procedures 

If you agree to be in this study, the following will happen to you: 



After you have plenty of time for all of your questions to be answered about this experimental procedure and you sign this informed consent form, several tests will be done. These tests help the doctor decide if you are eligible to take part in the study: 

-   you will be asked to give your complete medical history including past treatments for  CLL or SLL, current or past medical conditions and surgeries, and what medications you take 

-  you will have a physical examination.  

-  40 ml (2 and 1/2 tablespoons) of blood will be drawn for several blood tests including ‘routine safety’ labs such as a CBC (complete blood count that checks the number of various blood cells), and blood chemistries that check the function of you liver and  kidneys. In additional blood is drawn for ‘research’ purposes; see the ‘Optional  

    Procedures’ section below. 

-  chest x-ray 

-  electrocardiogram (EKG ) - a test that measures the electrical activity of your heart by placing sticky pads on your chest). 




Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

  10 pages 


Intanodal ISF35  


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-  10 mL (2 teaspoons) of blood taken for tests to determine if you have been exposed to, 

    or have an active infection with, certain viruses.  These viruses include Hepatitis B and 

    C Virus (HBV & HCV respectively), viruses which cause liver disease in their active  

    form, and  

-  Human Immunodeficiency Virus (HIV), the virus that causes acquired immune 

    deficiency (AIDS).  To have your HIV test performed, you will be asked to sign an 

    additional consent form required by the UCSD Medical Center.  If you have antibodies 

    (blood proteins formed by the immune system in response to foreign material) to HIV 

    in  your blood, you will not be eligible for this study.  A positive antibody test to 

    certain viruses is expected for some individuals and does not necessarily mean that you 

    have an active infection.  Dr. Castro and/or his associates, will discuss your lab results 

    with you and determine if you have an active viral infection requiring further treatment 

    and exclusion from this study, or if you do not have an active infection and are still  

    eligible for this study. 

-  Women who are able to have children must have a negative pregnancy test. 


Administration of ISF35 

If you are found to be eligible for this study, the following procedures and test will be done: 

a marrow biopsy (this is standard procedure that allows physicians to evaluate the 

extent of leukemia / lymphoma contained in the marrow). Another marrow biopsy 

may be required at the end of the follow up period (day 84 after injection of Ad- 


You will be admitted for this study to the General Clinical Research Center (GCRC) 

located in the main hospital of UCSD.  Ad-ISF35 will be injected directly into one 

selected lymph node located in your either in your neck, above the clavicle (collar 

bone), axilla (armpit area) or groin area.  The Interventional Radiologist will monitor 

the needle placement and directly perform the injection of the agent. The ultrasound 

imaging will continue during the injection to watch for any intravasation (leakage).   

The lymph node to be injected will be selected depending upon its size and how easy 

is to access, evaluate and inject that particular lymph node. This procedure will be 

performed under local anesthesia and using an ultrasound machine to locate the 

lymph node and determine that the virus is injected into the lymph node without 


A total of about 90 ml (6 tablespoons) of blood will be taken for routine blood tests 

and research studies at the time of admission.  

Vitals signs will be recorded several times during your hospitalization. 

You will remain hospitalized for observation for 24 hours. Prior to discharge you will 

have another physical exam and another blood test (30 mL about 2 tablespoons) 


Monitoring for Safety and Response 

You will be asked to return to UCSD clinic – 

48 hours after injection of Ad-ISF35, you will undergo: 

a complete physical examination and  

about 30 ml (2 tablespoons) of blood will be taken for routine blood tests and 


Day 7 after injection of Ad-ISF35, you will have: 




Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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another physical exam,  

blood collection of about 30ml (2 tablespoons) and  

Day 14, day 21, day 28, day 56, day 84, you will return to the UCSD clinic and undergo: 

a brief physical examination and  

about 30 ml (2 tablespoons) of blood will be taken for routine blood tests and 




Every 3 months, for 12 months after the injection of Ad-ISF35, you will be asked to return to 

clinic and the following procedures will be done: 

Physical examination including vital signs, lymph node, spleen and liver 

measurements, performance status, adverse event assessment, concurrent 

medications, and recording of transfusion of blood products; AND  

CBC with differential, platelet count, complete chemistry panel with uric acid, LDH 

                  and Beta-2 microglobulin  


At  the 12 month post visit only you will also have blood drawn for:  

Quantitative immunoglobulin levels (IgG, IgA, IgM) AND absolute T cell count  

      including CD3+, CD4+, and CD8+ populations.  



Optional Procedures - You do not have to agree to take part in the optional procedures in order 

to receive participate in this study. 


  1. Optional Blood Draws for Correlative Studies - If you agree, you will have about 2 teaspoons 

of blood drawn before the injection of ISF35, 48 hours after the injection and on study Days 7, 

14, 21, 28 56, and 84 to evaluate whether the ISF35 is stimulating your immune system, to 

evaluate how your immune system is responding, and to see the effects of the ISF35-treated cells 

on your leukemia cells.   


If you agree, leftover leukemia cells collected during this study will be stored in a tissue bank. 

These cells may be used in the studies of your immune system conducted by Dr. Castro and his 

colleagues at University of California, San Diego (UCSD). The collected leukemia cells, and 

their genetic information (DNA), may have significant therapeutic or commercial value.   



You agree to the Optional Blood Draws   

 Yes         No      Initials/Date: ________________________ 




   2.  Optional Quality of Life Questionnaire (QOL) - If you agree, you will complete a ‘QOL’ 

questionnaire to evaluate how the ISF35 affects your quality of life (QOL); this will be done 




Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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before you begin to receive ISF35, before your infusions, and 2 weeks and 2 months after your 

infusion.  Each of these questionnaires should take between 15 – 20 minutes to complete. 


You agree to the Optional Quality of Life Questionnaire   

 Yes         No      Initials/Date: ________________________ 



Duration of Participation 

Overall, your time on this study will be about 2 years.  During this period of follow-up, you may 

return to be seen by your primary care doctor.  Your doctor will be asked to provide information 

on any changes in your health and medical treatment from the end of the study until 2 years from 

your infusion.  If your disease worsens during the follow-up period, you may come off the study 

to begin standard treatment if needed. 


Study Risks 

Participation in this study may involve some added risks or discomforts.  These include: 


1.  ISF35  

ISF35 may cause flu-like symptoms such as fever, muscle and joint pain and stiffness, weakness, 

and/or nausea.  It may cause headache, diarrhea, low blood pressure, vomiting, difficulty 

breathing, and/or pain in various body areas.  It may cause significant loss of body water, 

difficulty sleeping, loose stools, night sweats, and/or increased sweating.  It may cause swelling, 

bloating, collection of abdominal fluid, constipation, skin rash, upset stomach, frequent 

urination, and/or a cough that brings up secretions.  It may cause running nose, sinus infection or 

inflammation, and/or weakness.  Your doctor may give you acetaminophen (Tylenol) for 

relieving flu-like symptoms.  


ISF35 may cause a decrease in blood platelets, red blood, or white blood cells.  If temporary 

reduction of platelets occurs, this may cause increased susceptibility to bruising and to bleeding; 

a decrease in red cells may cause you to become anemic and fatigued; a reduction of your white 

cells may cause increased susceptibility to infection; any of these could be life threatening and 

you may need a blood transfusion.   


ISF35 may cause increased liver enzymes, which may mean liver damage.  It may cause 

increased blood urea (a waste product made by the liver and excreted by the kidney) and/or 

decreased blood albumin (a protein found in blood that helps move water throughout the body), 

which may result in water gain in certain areas of the body. ISF35 may cause increased blood 

bilirubin (a byproduct of the breakdown of red blood cells), increased blood creatinine (a blood 

waste product), and/or high blood sugar.  

The frequent blood tests taken are meant to monitor for any changes in either blood cell counts 

or blood chemistries. 



CD154 protein 




Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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Your immune system may form antibodies (blood proteins formed by the immune system in 

response to foreign material) against the human or the mouse CD154 protein, which is part of 

ISF35.  While antibody formation against the mouse CD154 (present in the ISF35 virus) was 

observed in another study, this was not associated with any known safety risks.  However, it is 

not yet known whether the formation of these antibodies reduces the effectiveness of this new 

investigational procedure.  Antibodies against human CD154 have not been detected.  The 

formation of such antibodies may indicate a development of an immune reaction directed against 

cells other than the leukemia / lymphoma cells (risk of autoimmune disease). The purpose of 

giving you a lymph node injection with ISF35 is to altered leukemia / lymphoma cells contained 

in the lymph node and stimulate your immune system to recognize and to attack your leukemia / 

lymphoma cells.  This will be a positive effect if the body recognizes the leukemia / lymphoma 

cells and works to destroy them.  However, it is possible that the immune system also may attack 

other cells, causing unwanted autoimmunity, a condition in which the body attacks its own 


In this study, blood tests are done at regular intervals to detect the formation of antibodies. 


Ad-ISF35 is intended to activate the immune system against the leukemia cells.  There are other 

methods being developed to activate the immune system that are also being studied in humans 

with cancer and other diseases.  Activating the immune system could bring about  an immune 

response against the cancer cells but could also cause unwanted side effects and toxicities.  


One method of activating the immune system, which is not related to this study, uses antibodies 

to activate the immune system.  One study used antibodies that attach to the surface of immune 

cells (T cells).  When these antibodies were given to normal volunteers in a study conducted in 

Europe (TeGenero TGN1412), the treated patients had unexpected and serious toxic effects.  

These effects included severe headaches, muscle aches, nausea, diarrhea, redness of the skin and 

low blood pressure, fluid involving the lungs, kidney damage and blood clotting problems. Two 

patients had damage to the heart and lungs that required prolonged treatment in the intensive care 

unit and hospitalization.  Despite of the severity of these responses, all the treated subjects 

survived and were able to leave the hospital.  However, some of the patients still have medical 

problems that have yet to resolve.  Although this study is unrelated to the current study and uses 

entirely different technology, it is an example of a strong immune response that can have very 

serious consequences. 


Adenovirus Vector 

Adenoviruses are a common cause of colds. The vector might cause shortness of breath and/or 

allergic reactions, including hives, skin rash, difficulty breathing, and/or fever.  They can cause 

lung infections that generally are not serious and go away on their own.  However, on rare 

occasions, adenoviruses can cause cough, bronchitis, and pneumonia that can be serious and 

conceivably life threatening.  Also, the adenovirus can infect the liver.  This may cause hepatitis 

(inflammation of the liver), jaundice (yellowing of the skin or whites of eyes), or liver failure, 

and thus could be life-threatening.  The injection ofAd-ISF35 will be local and no major leak  








Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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into the blood system is expected. However, this is a safety concern as the adenovirus could 

infect other organs of the body, leading to unknown problems and potential life-threatening 

reactions which could include damage of vital organs such as the liver and spleen as well as 

activation of the immune system against your own cell and tissues, a process that is called 

autoimmunity..  At another institution, in a gene therapy trial that was unrelated to this trial, a 

subject was injected with a large amount of adenovirus and the subject subsequently died.  In this 

clinical trial, the virus will be delivered locally into a lymph node, and all efforts are made to 

reduce the amount of virus leak that potentially can enter the blood.  Also, the adenovirus used in 

this protocol is ‘crippled’ and is not able to reproduce itself inside your body because the 

essential parts for reproduction were removed. 

There is a small chance that there may be normal infective virus in the preparation that you will 

receive. There is also a small chance that this virus or the virus vector may be excreted for a 

short period of time in your body fluids. Close friends and family members should avoid contact 

with your body fluids for a period of two (2) weeks after the administration of the virus vector. 


2.   Lymph node injection with Ad-ISF35 

The procedure will be performed under local anesthesia using lidocaine (local anesthesia 

medication). However, Ad-ISF35 injection can cause local pain and discomfort during the 

injection and during the following days after the injection is performed. The local reactions are 

unknown but could include redness of the skin, pain, infection and potentially damage or loss of 

the local skin and tissue where the injection was performed. The ultrasound procedure that will 

be used for localization and injection of the lymph node is painless and does not have associated 

side effects. 

There is a small risk that you may experience low blood pressure and/or temporary shifts 

(increases and decreases) in the mineral content of your blood.  Slight abnormalities in the 

mineral content of your blood could result in muscle twitching or a tingling sensation, 

particularly around the mouth.  More severe abnormalities in the mineral content of your blood 

could result in tetany (severe muscle contractions) or abnormal electrical activity in your heart, 

either of which could be fatal.  Because of this, you will be monitored closely for changes in 

your blood pressure and symptoms that may indicate a change in the mineral content of your 



3.  Other Medications  

Antibiotics are used to prevent infection during the preparation of your leukemia cells in the 

laboratory. You may experience an allergic reaction against some of the antibiotics.  

Medications that can be used to manage an allergic reaction include antihistamines, steroids, 

oxygen, epinephrine (adrenaline), and medications used to maintain blood pressure.  For life- 

threatening allergic reactions, it may be necessary to place a breathing tube in your airway.  A 

breathing machine (mechanical ventilator) could then be used to assist with your breathing until 

you have recovered. 










Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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5.  Radiation Risk  - As a result of participating in this study, you will be exposed to a small 

amount of radiation (approximately 0.024 cGy). This amount is less than you would 

receive from a year of natural exposure, approximately 0.16 cGy. This dose should not be 

harmful. If you are especially concerned with radiation exposure or you have had a lot of x-rays 

already, you should discuss this with your doctor. 


6.  Blood Draws - the risk of having blood drawn through a vein includes pain, bruising, 

swelling, irritation at the site of the blood draw, and rarely an infection could develop.  You may 

feel dizzy, lightheaded or faint when blood is taken; if you are prone to fainting, please inform 

your doctor prior to having blood drawn.  


7.  Risks of Hepatitis Testing - Testing for hepatitis viruses may result in a diagnosis of 

infection with these viruses. You will be informed of the results of these tests; if you do not wish 

to know the results, you should refuse to participate in this study. In the event that you are 

diagnosed with hepatitis, you may be referred to a doctor who specializes in these illnesses. The 

diagnosis of hepatitis may result in earlier treatment and/or prevention of many complications 

from the illnesses. Efforts will be made to keep your personal information confidential. 

Awareness of a diagnosis of these illnesses may have serious person or social consequences.  

Some of these consequences include possible difficulty obtaining health insurance or 

employment, and difficulty traveling to some foreign countries. 


8.  Bone Marrow Biopsy – For a marrow biopsy and aspirate, you will be given a numbing 

medicine and a special needle will be put into the center of your (hip) bone. The marrow aspirate 

will be drawn into a syringe.   A marrow biopsy is similar to a marrow aspiration, except a 

sample of bone is removed through the needle.  It is very painful when marrow is removed but 

pain will last only last 15 – 30 seconds.  However, the area may be sore for a day or two.  It is 

very rare, but you may have an allergic reaction to the numbing medicine; this reaction may 

include swelling in the throat, difficulty breathing, changes in heart rate or blood pressure, rashes 

or even death in rare cases.  A large amount of bleeding or an infection are possible but are rare. 


9.  Blood Test - DNA/Gene Profiling - Your white blood cells and the DNA that they contain 

may be used in additional research to be conducted by the University of California. Your blood 

and its derivatives (DNA, which is the genetic material insides your cells), may have significant 

therapeutic or commercial value.  You consent to such uses.  

Your samples will be kept indefinitely. There will be no direct benefit to you from these studies 

since you will not be provided with any results or information regarding your DNA gene profiling 

tests.  Dr. Castro and his colleagues, however, may learn more about CLL. 


Instances are known in which a subject in research has been required to furnish genetic 

information as a precondition in applying for health insurance and/or a job.  Participation in this 

study does not mean that you have had genetic testing. Genetic testing means having a test 

performed and the results provided to you and your doctor. If you are interested in having  








Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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genetic testing performed you should consult your doctor, as some commercial tests are 

available. Further, should this information be accidentally divulged to the wrong source you or 

your family might be discriminated against in obtaining life or health insurance, employment or 

ability to adopt children. 


10.  Reproductive Risks 

If you are a female and capable of child-bearing, a sample of urine or blood will be collected 

before the study is begun in order to be as sure as possible that you are not pregnant.  Your 

participation requires that you use a birth control method, such as abstinence, diaphragm, 

condom or intrauterine device to prevent pregnancy during the study, as the IDF35 being tested 

may cause harm to an unborn child.  If you miss a period or think you might be pregnant, you 

will notify the doctor.  You may have to withdraw from the study 

All participants (including men who have not been surgically sterilized) are required to use an 

effective birth control method of their choice including barrier methods (condoms, diaphragm), 

oral, injectable, implant birth control, or abstinence to ensure that pregnancy does not occur 

while being treated on this study and for at least two (2) weeks after the last virus vector 



11.  Transfusions 

The likelihood of requiring a blood transfusion is not expected to increase due to your 

participation in this study. However, patients with CLL or SLL may require transfusions because 

of anemia or low platelet counts.  If a blood transfusion is required, potential risks of transfusion 

due to anemia and/or low platelet count may include: discomfort and anxiety, breathing 

difficulty, facial flushing, severe pain in the neck, the chest and especially the low back area.  

Evidence of shock may appear, including a rapid feeble pulse, cold clammy skin, shortness of 

breath, a drop in blood pressure, nausea and vomiting. Onset of these symptoms usually occurs 

during or immediately after transfusion. Other side effects include: fever, allergic reaction, and 

too much build up of fluid, which may cause congestive heart failure, chills and death. 


Infectious agents such as HIV and Hepatitis B and C may be transmitted by transfusions.  The 

University of California San Diego Blood center routinely screens for these infectious agents. 


12.  Unknown Risks 

Since this is an experimental agent there may be some unknown risks that are currently 

unforeseeable.  You will be informed of any significant new findings. 


Study Benefits  

The main purpose of this protocol is to assess the safety of the experimental agent.  In the 

preceding study, subjects who received a single infusion of genetically altered leukemia cells,  

had reduced lymph node swelling, a decrease in their leukemia cell counts, and an increase in the 

number of some specialized non-leukemic white blood cells (T-lymphocytes). However, it is 

unknown whether a single lymph node injection of ISF35 will be beneficial to you. 







Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


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Alternatives to Participation in this Study 

At present, there is no cure for CLL.  Treatments for relief of symptoms are available if 

treatment is indicated.  Patients who have received treatment for advance stage CLL may be 

treated with other types of chemotherapy, radiation therapy, stem cell transplantation (if 

eligible), or may receive no specific treatment other than for symptoms such as blood product 

transfusions or pain medications.  Those patients with untreated advance stage CLL may be 

treated with chemotherapy, radiation therapy, stem cell transplantation (if eligible), or may 

receive no specific treatment other than for symptoms such as blood product transfusions or pain 

medications.  Also, none of the mentioned standard treatments for CLL has been shown to 

prolong survival in treated patients, but they may improve some symptoms associated with this 

disease. The study doctor will discuss these options with you. 


Voluntary participation  

Taking part in this research study is your decision.  You may decide to stop at any time without 

jeopardy to the medical care you will receive at this institution or loss of benefits to which you 

are entitled.  You should tell the study doctor if you decide to stop and you will be advised 

whether any additional tests may need to be done for your safety.  




Dr. Castro, his research team, the UCSD Investigational Review Board, the U.S. FDA, and 

governmental agencies in other countries where the study drug may be considered for approval, 

will have access to confidential information that could be linked to your name. Research records 

will be kept confidential to the extent allowed by law. 


Compensation for Participation 

There will be no payment made to you for participation in this study.  ISF35 is investigational 

(not approved by the FDA) and will be provided by Memgen LLC (a biotechnology company 

located in San Diego, CA) at no cost to you. Memgen is not sponsoring this study, will not have 

access to your medical records, and your privacy will be protected according to HIPAA 


Costs associated with the standard and customary care of your leukemia/lymphoma will be billed 

to your insurance provider or third party payer.  If your third party payer, or insurance provider 

does not cover the routine medically prudent care for the treatment of your leukemia/lymphoma, 

you may be responsible for the total amount of those charges.  All research related costs, such as 

research related laboratory tests, diagnostic tests, and the process involved in the production of 

ISF35 for injection will be not be charged to you. 


Compensation for Injury 

If you are injured as a direct result of participation in this research, the University of California 

will provide any medical care you need to treat those injuries. The University will not provide 

any other form of compensation if you are injured.  You may call the UCSD Human Subjects 

office at (858) 455-5050 for more information about this or to report research-related problems.   





Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 



Intanodal ISF35  


Page 10 of 10 


Withdrawal from Study 

You may be withdrawn from the study if Dr. Castro believes that it is in your best medical 

interest, or if you do not follow the instructions given you by the study personnel. You may also 

decide that you no longer wish to continue in this study.  

At the time of withdrawal, you will have a final physical examination, and blood will be taken 

for routine safety labs. 



Agreement to Participate 



Dr. ________________ has explained this study to you and answered your questions.  If you 

have other questions or research-related problems, you may call Dr. Castro at (858) 822-6600. 

After hours or on weekends, please call the page operator at (858) 657-7000 and ask to speak 

with the oncologist on call.   



You have received a copy of this consent document and a copy of the Experimental Subject's 

Bill of Rights to keep. 



You agree to participate. 



___________________________     _________________________       _______________ 

Subject's signature                     Subjects Printed Name            Date 




____________________________     _______________ 

Witness                                                Date        





Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008