Phase III Randomized Study of Intensive Therapy for T-Cell Acute Lymphoblastic Leukemia and Advanced Lymphoblastic Non-Hodgkin's Lymphoma (the T-4 Study): Multiagent Chemotherapy with vs without Dexrazoxane Cardioprotection and with vs without High-Dose MTX
Note: this outline was patched together from the NCI online protocol and input from parents of kids with ALL. It is summarized here for our convenience, so that we can quickly compare our protocols. We do not guarantee the accuracy of this outline - it is not an official document. You can contact your child's oncologist and ask for the complete protocol document if you are interested in the details of your child's protocol.
POG 9404 NCI PDQ (takes you to the cancer.gov site)
The main purpose of this study is to determine whether adding high dose methotrexate to other chemotherapy drugs is more effective in treating T-ALL and T-NHL.
Another purpose is to determine whether Zinecard (DZR) ,a drug that is felt to prevent heart damage related to Doxorubicin in adults will do so in children. The combination of anti cancer medicines consists of a three part administration of drugs and a course of radiation therapy to induce a state of no apparent disease.
Patients will be randomized twice. The first randomization will be to receive or not to receive high dose methotrexate. Patients who receive high dose methotrexate will receive four doses along with the" standard " combination therapy.The second randomization will be to receive or not receive Zinecard. Patients who receive Zinecard will receive it just before each dose of Doxorubicin. Expected duration of therapy is 108 weeks. There are three phases of therapy.
First, during the phase called induction (weeks 1-6) patients will receive:
Patients will be randomized to receive high dose methotrexate on day 22. This high dose methotrexate therapy will be given as a continuous infusion.This therapy will last at least 24 hours and necessitate being admitted to the hospital.All patients will receive 3 drugs (methotrexate, Ara-C, hydrocortisone) to prevent central nervous system disease. The drugs will be injected into the spinal fluid simultaneously on different occasions over the entire three phases of the treatment. Patients who already have central nervous system disease will receive an additional 2 doses of this combination.
After a disease free state has been attained, all patients will receive a sequence of drug combinations. During this phase of therapy called Consolidation (weeks7-33) drugs will be given in three week cycles (6-mercaptopurine by mouth for 14 days vincristine and doxorubicin by vein on day1 of the cycl, prednisone by mouth for 5 days) with or without Zinecard by vein. Asparaginase will also be given into the muscle during the consolidation phase once a week for weeks 7-26. Patients who received high dose methotrexate on day 22 of induction will also receive it on weeks 7,10 and 13 of consolidation by continuous infusion. At weeks 22-24 the patient will receive radiation therapy to the brain.
During this phase of therapy called Continuation (weeks34-108) patients will receive vincristine by vein,prednisone by mouth (every day for five days)and 6-mercaptopurine by mouth (every day x 14 days) every three weeks.Methotrexate by vein or intramuscularly, will be given every week except during those weeks when the patient will receive the medications into the spinal fliud.
TIT's are given on weeks 1 thru 6, 10, 16, 22, 40, 58, 76, 94, and108. Chest Xrays are done weeks 1,4,7,16,34,52,79,and108. Cardiac Echo's are done weeks 1, 4, 31, 52, 79, and108. Cranial Radiation-Begin week 22. 1800 cGy to cranium. Start with Day 1 of cycle which begins week 22 of therapy or later.
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Last Updated 4/06
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