- Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as measured by a scored neurologic examination, in young patients undergoing vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.
- Compare the frequency and types of neurotoxicity observed in patients treated with glutamic acid versus placebo.
- Determine if a greater proportion of patients receiving glutamic acid are able to receive 100% of their scheduled doses of vincristine versus those not treated with glutamic acid.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease and duration of planned vincristine-containing treatment (Wilms' tumor or rhabdomyosarcoma with treatment planned for ≥ 9 consecutive weeks [stratum 1] vs acute lymphoblastic leukemia or non-Hodgkin's lymphoma with treatment planned for ≥ 4 consecutive weeks [stratum 2]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.
- Arm II: Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.
All patients undergo neurologic examination at baseline and at 5 weeks. Patients in stratum 1 also undergo additional neurologic examination at week 10.
PROJECTED ACCRUAL: A total of 208 patients will be accrued for this study.
- Undergoing vincristine-containing treatment for any of the following newly diagnosed malignancies:
- Wilms' tumor or rhabdomyosarcoma
- Scheduled to receive ≥ 9 consecutive weeks of vincristine-containing chemotherapy regimen
- Acute lymphoblastic leukemia or non-Hodgkin's lymphoma
- Scheduled to receive ≥ 4 consecutive weeks of vincristine-containing chemotherapy regimen and concurrent steroid therapy
- No underlying neuromuscular disease or peripheral neuropathy
- Normal baseline peripheral neurologic exam
- No primary intracranial malignancy
- No seizure disorders
- No family history of Charcot-Marie-Tooth disease
- No recent history of Guillain-Barre syndrome
PRIOR CONCURRENT THERAPY:
- No concurrent itraconazole
- No regular use of laxatives or stool softeners prophylactically for constipation prior to chemotherapy
- No concurrent enrollment on another investigational protocol involving a study agent that is provided under an IND
Last updated: 05/03/2011