Clinical Trials

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients Receiving Vincristine for Wilms' Tumor, Rhabdomyosarcoma, Acute Lymphoblastic Leukemia, or Non-Hodgkin's Lymphoma

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

NCT ID:

NCT00369564