Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

Phase 2

Completed

Conditions: Lymphoma
Neurotoxicity
Peripheral Neuropathy
Sarcoma
Kidney Cancer
Leukemia

Interventions: Drug: Glutamine
Other: Placebo

Registration Number: NCT00365768

Lead Sponsor: Columbia University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

Inclusion Criteria

Patients between the age of 5 and 21 years old.
Patients who demonstrate the ability to complete the assessment instruments at baseline.
Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.

Exclusion Criteria

Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
Patients with recurrent disease.
Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
Patients with hepatic encephalopathy or hyperammonemia.
Patients with a focally abnormal neurologic exam.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I: Glutamine	Glutamine	Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Arm II: Placebo	Placebo	Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.

Primary Outcome Measures