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

NCT ID: NCT00365768

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Kidney Cancer; Leukemia; Lymphoma; Neurotoxicity; Peripheral Neuropathy; Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm I: Glutamine

Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.

Group Type: EXPERIMENTAL

Glutamine

Intervention Type: DRUG

Administered orally twice daily for 21 days

Arm II: Placebo

Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administered orally twice daily for 21 days

Interventions

Glutamine

Administered orally twice daily for 21 days

Intervention Type: DRUG

Placebo

Administered orally twice daily for 21 days

Intervention Type: OTHER

Other Intervention Names

Nutritional Supplement

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Julia Glade Bender

Irving Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia L. Glade-Bender, MD

Role: PRINCIPAL_INVESTIGATOR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-ICCR-3349

Identifier Type: OTHER

Identifier Source: secondary_id

AAAA6806

Identifier Type: -

Identifier Source: org_study_id