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

July 25, 2016 updated by: Julia Glade Bender, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I: Glutamine
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Drug: Glutamine
Administered orally twice daily for 21 days
Other Names:
  • Nutritional Supplement
PLACEBO_COMPARATOR: Arm II: Placebo
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Other: Placebo
Administered orally twice daily for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Vincristine-induced Peripheral Neuropathy
Time Frame: Up to 30 weeks from baseline while on Vincristine treatment
Up to 30 weeks from baseline while on Vincristine treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Progression of Neuropathy
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (ESTIMATE)

August 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA6806
  • CPMC-ICCR-3349 (OTHER: Columbia University Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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