Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Condition: Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma
MeSH terms: Lymphoma; Leukemia; Sarcoma; Kidney Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known
      whether glutamine is more effective than a placebo in treating neuropathy caused by
      vincristine.

      PURPOSE: This randomized phase II trial is studying glutamine to see how well it works
      compared to a placebo in treating neuropathy caused by vincristine in young patients with
      lymphoma, leukemia, or solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the incidence of vincristine-induced peripheral neuropathy in pediatric
           patients with lymphoma, leukemia, or solid tumors.

      Secondary

        -  Compare the safety of glutamine vs placebo in these patients.

        -  Compare the efficacy of glutamine vs placebo in reducing the progression and/or
           resolution of vincristine-induced peripheral neuropathy in these patients.

        -  Compare the effect of glutamine supplementation vs placebo on chemotherapy-related
           toxicities in these patients.

        -  Compare the effect of glutamine vs placebo on measures of quality of life in these
           patients.

        -  Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor
           and glutamine levels in these patients.

        -  Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients
           receive oral glutamine twice daily on days 1-21.

        -  Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients
           receive oral placebo twice daily on days 1-21.

      Patients in both arms undergo neuropsychological and clinical neurological assessment, blood
      collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and
      quality of life assessment on days 1, 21, and 42.

      After completion of study treatment, patients are followed for an additional 21 days.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
    

Intervention name(s): Glutamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered orally twice daily for 21 days; Administered orally twice daily for 21 days
Other intervention name(s): Nutritional Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage II childhood small noncleaved cell lymphoma; stage I Wilms tumor; stage II Wilms tumor; stage III Wilms tumor; stage IV Wilms tumor; stage V Wilms tumor; childhood grade III lymphomatoid granulomatosis; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; stage I childhood large cell lymphoma; stage I childhood lymphoblastic lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; stage IV childhood lymphoblastic lymphoma; stage IV childhood small noncleaved cell lymphoma; childhood Burkitt lymphoma; stage III childhood small noncleaved cell lymphoma; untreated childhood acute lymphoblastic leukemia; childhood nasal type extranodal NK/T-cell lymphoma; previously untreated childhood rhabdomyosarcoma; localized Ewing sarcoma/PNET; metastatic Ewing sarcoma/PNET; neurotoxicity; peripheral neuropathy