Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
Condition: Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma
MeSH terms: Lymphoma; Kidney Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is
      not yet known whether glutamic acid is more effective than a placebo in preventing nerve
      damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute
      lymphoblastic leukemia, or non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works
      compared to a placebo in reducing nerve damage caused by vincristine in young patients
      receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or
      non-Hodgkin's lymphoma.
    

Detailed description: 
      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 250 patients will be accrued for this study.
    

Intervention name(s): glutamic acid; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally 3 times daily; Given orally 3 times daily
Other intervention name(s): l-glutamic acid hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: neurotoxicity; peripheral neuropathy; stage I Wilms tumor; stage II Wilms tumor; stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; previously untreated childhood rhabdomyosarcoma; childhood grade III lymphomatoid granulomatosis; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; stage I childhood large cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; stage I childhood lymphoblastic lymphoma; stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; childhood Burkitt lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood small noncleaved cell lymphoma; stage III childhood small noncleaved cell lymphoma; stage IV childhood small noncleaved cell lymphoma; untreated childhood acute lymphoblastic leukemia