Clinical trial NCT00365768
Conditions: Kidney Cancer Leukemia Lymphoma Neurotoxicity Peripheral Neuropathy Sarcoma
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
Sponsor: Columbia University
Start date: 2004-10-01; Completion date: 2012-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. arm 2: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Interventions: intervention 1: Glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally twice daily for 21 days intervention 2: Administered orally twice daily for 21 days

Protocol documents: