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

Lymphoma Clinical Trial

Official title:

A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365768
• Other study ID #: AAAA6806
• Secondary ID: CPMC-ICCR-3349
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: February 3, 2014
• Start date: October 2004
• Est. completion date: June 2012

Study information

• Verified date: February 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Kidney Cancer
• Leukemia
• Lymphoma
• Neurotoxicity
• Neurotoxicity Syndromes
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Sarcoma

Intervention

Drug:
• Glutamine
Administered orally twice daily for 21 days

Other:
• Placebo
Administered orally twice daily for 21 days

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vincristine-induced peripheral neuropathy		42 days	Yes
Secondary	Neurological status as measured by neuropsychological assessment, clinical neurological examination, and serum markers		42 days	Yes
Secondary	Quality of life (QOL) as measured by the Pediatric Cancer QOL Inventory		42 days	No