CONSENT FORM
TREATMENT REFERRAL CENTER PROTOCOL – TRC 9701
COMPOUND 506U78 (NSC 686673) IN PATIENTS WITH RELAPSED OR
REFRACTORY T-CELL ALL OR T-CELL LYMPHOBLASTIC LYMPHOMA
This is a clinical trial called a Treatment Referral Center Protocol (a type of research study). A
treatment Referral Center Protocol is a way that the National Cancer Institute works with
physicians to allow a patient to receive an investigational (research) drug. Treatment Referral
Center Protocols include only patients who choose to take part. Please take your time to make
your decision. Discuss it with your friends and family.
You are being asked to take part in this research study because you have T-Cell Acute
Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma that either did not respond to
chemotherapy or has come back following chemotherapy.
WHY IS THIS STUDY BEING DONE?
This study is being done because the commonly used chemotherapy treatment for T-cell
leukemia/lymphoma does not work for some patients, or the beneficial effects wear off.
You are being asked to take part in this research study because standard chemotherapy
is no longer an effective treatment option for you and you are not eligible for any other
clinical trials for the treatment of T-cell acute lymphoblastic leukemia or T-cell
lymphoblastic lymphoma.
The purpose of this study is to provide you with a new investigational chemotherapy
drug, Compound 506U78, which is not yet commercially available to you for treatment.
Compound 506U78 has been found to have activity (that is, cause remissions) in a
limited number of other patients with T-cell leukemia/lymphoma. In this study, we
want to make this treatment available to you since standard treatment is no longer an
option. During your treatment we will test how long any positive effects last and how
bad any side effects are.
WHAT IS INVOLVED IN THE STUDY?
Tests:
Taking part in this study involves several tests and procedures. Some of these tests
would be done even if you do not take part in the study:
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Blood tests
Urine tests
Physical exam
Bone marrow sampling procedure
Nervous system tests (physical exams and mental questionnaires)
Depending on the condition of your leukemia/lymphoma, some other tests that you may
or may not have done as part of this study are:
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Spinal tap (to remove a small amount of fluid from around the spinal cord)
CT scans
MRI scans
Chest x-ray
Other x-ray studies
Procedures:
In this study you will receive Compound 506U78 for 3 treatments during a one-week
period. The treatments will be scheduled for every other day. Compound 506U78 will
be given into your vein over two hours. If your leukemia/lymphoma responds to this
treatment, the 3 treatments can be repeated every twenty-one days, which is called a
course. You may continue to receive this therapy for up to twelve courses as long as
you do not experience unacceptable side effects.
If you wish to be a part of this study, you may receive your first few courses of
Compound 506U78 in the hospital. Depending upon how well your doctor thinks you
handle the therapy, treatments may be given on an outpatient basis in the hospital’s
outpatient clinic. While you are an outpatient, you may be asked to see your physician
regularly. Your doctor will run routine blood tests, X-rays, and other diagnostic
procedures to watch for side effects and check your response to this treatment.
HOW LONG WILL I BE IN THE STUDY?
This will depend on how well your leukemia/lymphoma responds to the Compound
506U78 and the severity of any side effects you may experience. Treatment may be up
to 12 courses (approximately nine months). However if you get 3 courses of treatment
without any evidence of benefit, then you will be taken off this study. We would also
like to keep track of your medical condition for the rest of your life to look at the longterm effects of this therapy.
During your treatment, if there are significant new study findings that may affect your
treatment, they will be discussed with you. In addition, if the Compound 506U78
treatment does not seem to be helping you or if the side effects are too severe, treatment
may be stopped by your doctor, without your prior approval.
You can stop participation at any time. However, if you decide to stop participating in
the study, we encourage you to talk to the researcher and your regular doctor first.
WHAT ARE THE RISKS OF THE STUDY?
While on the study, you are at risk for the side effects. Most of them are listed below
but they will vary from person to person. You should discuss these with the researcher
and/or your regular doctor. Drugs will be given to make some of the side effects less
serious and uncomfortable. There also may be other side effects that we cannot predict.
Many side effects go away shortly after the Compound 506U78 is stopped, but in some
cases side effects can be serious, long-lasting, or permanent.
Nervous system risks:
Likely:
 Severe sleepiness
 Shakiness
 Confusion
 Headache
 Changes in sensation such as numbness or tingling
 Weakness
 Difficulty walking
Possible:
 Blurred vision
 Balance problems
 Light-headedness
 Decreased reflexes
Less likely but serious:
 Convulsions or seizures
 Paralysis (may be permanent)
 Problems breathing because of severe weakness (may be permanent)
Other risks:
 Eye pain
 Irritation of the eye with redness and itching
 Diarrhea
 Nausea
 Vomiting
 Appetite changes and weight loss
 Inflammation of the pancreas
 Muscle aches and pains
 Swelling
 Fever
 Low blood pressure
 Temporary decreased blood cell counts may cause:
 Increased chance of infections
 Bleeding
 Tiredness
Reproductive Risks: Because Compound 506U78 can affect an unborn baby, you
should not become pregnant or father a baby while on this study. You should not nurse
your baby while on this study. Ask about counseling and more information about
preventing pregnancy.
ARE THERE BENEFITS TO TAKING PART IN THIS STUDY?
There may or may not be direct medical benefit to you for taking part in this study. If
you respond to this drug it may cause a decrease or disappearance of your
leukemia/lymphoma and a decrease in your symptoms, but this cannot be predicted.
We hope the information learned from this study will help future patients with your
type of leukemia/lymphoma.
WHAT OTHER OPTIONS ARE THERE?
Instead of being on this study, you have these options:
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Other experimental treatments or investigational drugs.
No further anticancer therapy and comfort care only.
Please ask your doctor any questions you may have to help you make your decision.
WHAT ABOUT CONFIDENTIALITY?
Efforts will be made to keep your personal information confidential. We cannot
guarantee absolute confidentiality. Your personal information may be disclosed if
required by law.
The following organizations may look at and/or copy your research records, for quality
assurance and data analysis:
 National Cancer Institute
 Food and Drug Administration
 Glaxo Wellcome (the company that makes Compound 506U78)
WHAT ARE THE COSTS?
The National Cancer Institute will provide Compound 506U78 to your doctor free of
charge. If, during the study, Compound 506U78 commercially available, you may have
to pay for the amount of drug needed to complete the study.
If you get hurt or ill from this study, you will receive emergency medical treatment, but
it will be charged in the regular way. No funds have been set aside to compensate you
in the event of injury.
You or your insurance company will be charged for continuing medical care and/or
hospitalization in the regular way.
Please ask about any expected added costs or insurance problems.
You will not be paid for taking part in this study.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or
may leave the study at any time. Leaving the study will not result in any
penalty or loss of benefits to which you are entitled.
We will tell you about new information that may affect your health, welfare, or
willingness to stay in this study.
For questions about the study or a research-related injury, contact the researcher,
NAME
, at TELEPHONE NUMBER
.
In addition, you may contact your physician, ________________________ or other
staff members at _____________________________ to answer questions about the
treatment procedure, treatment related questions, or research related injuries.
For questions about your rights as a research participant, contact the NAME OF
CENTER Institutional Review Board (which is a group of people who review the
research to protect your rights) at TELEPHONE NUMBER or NAME OF ANOTHER
CONTACT at TELEPHONE NUMBER who can answer questions about patient’s
rights.
WHERE CAN I GET MORE INFORMATION?
You may call the NCI’s Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) or TTY: 1-800-332-8615.
Visit the NCI’s Web sites…
cancerTrials: comprehensive clinical trial information http://cancertrials.nci.nih.gov.
CancerNet: accurate cancer information including PDQ http://cancernet.nci.nih.gov.
You will get a copy of this consent form. You can request additional information
from your physician.
SIGNATURE
I agree to take part in this study.
Participant ________________________________________ Date______________________