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

This study is currently Recruiting

December 2008 By National Cancer Institute (NCI)

First Recieved on August 16, 2006

Last Updated on February 24, 2010

Sponsor: Herbert Irving Comprehensive Cancer Center
Collaborators:
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00365768

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Eligibility

Ages Eligible for Study:5 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

DISEASE CHARACTERISTICS: - Diagnosis of any of the following: - Acute lymphoblastic leukemia - Non-Hodgkin's lymphoma - Ewing's sarcoma - Wilms tumor - Rhabdomyosarcoma - Newly diagnosed disease - No recurrent disease - No primary or metastatic CNS tumors - Must have documented, clinically mild peripheral neuropathy identified by 1 of the following criteria: - Clinically progressive neurologic findings as defined by an increase in 1 toxicity grade by NCI CTC v3.0 on clinical exam - Clinically progressive neuropsychological findings as determined by neuropsychological examination and defined by the following: - At least ? standard deviation from the baseline score on any of the following 3 neuropsychological instruments that measure both fine and gross motor functioning: - Symbol Digit Modalities Test - Hand Dynamometer Test (Grip Strength Test) - Purdue Pegboard Test - Currently receiving an expected cumulative dose of ? 15 mg/m^2 of vincristine over a 30-week period - Maximum prior cumulative dose of vincristine ? 8 mg/m^2 - No preexisting neurologic disease, including grade II, III, or IV neurological status by NCI CTC v3.0 on clinical exam PATIENT CHARACTERISTICS: - No hepatic encephalopathy or hyperammonemia PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Investigators

  • Investigator: Julia L. Glade-Bender, MD - Principal Investigator - Herbert Irving Comprehensive Cancer Center

Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York 10032 United States

Conditions related to this trial:

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