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

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University of California, San Diego 

Consent to Act as a Research Subject 

 

 

A PHASE 1, OPEN LABEL, DOSE-ESCALATION, PHARMACODYNAMIC STUDY OF 

INTRANODAL INJECTION OF ADENOVIRUS-CD154 (Ad-ISF35) IN PATIENTS 

WITH CHRONIC LYMPHOCYITC LEUKEMIA / SMALL LYMPHOCYTIC 

LYMPHOMA 

 

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: 

 

Screening  

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). 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

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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- 

ISF35).  

- 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 

leaks.   

- 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 

research.  

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

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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 

research.  

 

Follow-up 

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 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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 

tissues. 

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  

 

 

 

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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 

blood. 

 

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. 

 

 

 

 

 

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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  

 

 

 

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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 

treatment. 

 

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. 

 

 

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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.  

 

 

Confidentiality 

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 

regulations.   

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.   

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008 

 

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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        

 

 

 

Approved 

Initial Approval: 2/16/2006 

Current Approval: 7/19/2007 

Do not use after: 1/17/2008