Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer

Last updated: July 22, 2021
Sponsor: University of South Florida
Overall Status: Completed

Phase

3

Condition

Kidney Cancer

Lymphoma

Leukemia

Treatment

N/A

Clinical Study ID

NCT00369564
SCUSF 0402
SCUSF 0402
ACCL 0731
5U10CA081920-11
  • Ages 3-20
  • All Genders

Study Summary

RATIONALE: Glutamic acid may help lessen or prevent nerve damage caused by vincristine. It is not yet known whether glutamic acid is more effective than a placebo in preventing nerve damage in patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying glutamic acid to see how well it works compared to a placebo in reducing nerve damage caused by vincristine in young patients receiving vincristine for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • Patients ≥ 3 and < 21 years of age at the time of study registration.
  • Patients newly diagnosed with Wilm's tumor and scheduled to receive at least 9consecutive weeks of chemotherapy with a vincristine-containing regimen.
  • Patients newly diagnosed with rhabdomyosarcoma and scheduled to receive at least 9consecutive weeks of chemotherapy with a vincristine-containing regimen.
  • Patients newly diagnosed with ALL and scheduled to receive 4 consecutive weeks ofchemotherapy with a vincristine-containing regimen with accompanying steroid therapy.
  • Patients newly diagnosed with Non- Hodgkins Lymphoma (NHL) and scheduled to receive 4consecutive weeks of chemotherapy with a vincristine-containing regimen withaccompanying steroid therapy.
  • Patients with no underlying neuromuscular disease or peripheral neuropathy

Exclusion

EXCLUSION CRITERIA:

  • Abnormal baseline peripheral neurologic exam (i.e. or peripheral neuropathy)
  • Patients with:
  • seizure disorders
  • primary intracranial malignancy
  • family history of Charcot Marie Tooth Disease
  • a recent history of GuillianBarré26
  • Patients receiving concomitant itraconazole are at risk for increased vincristinetoxicity and therefore are ineligible.
  • Patients who are regularly using laxatives or stool softeners for constipation at thetime of enrollment are not eligible to participate in the study. Likewise, sinceprevention of neuro-constipation will be evaluated, patients with an ongoing historyof constipation that has required frequent use of laxatives or stool softeners shouldnot be enrolled.
  • Patients should not be scheduled to receive laxatives or stool softenersprophylactically to prevent constipation, as the prevention of neuro-constipation willbe evaluated in this study; however, when patients show signs of developingconstipation while on chemotherapy, as determined by the treating physician, they maybe treated with laxatives or stool softeners at the clinician's discretion. Use oflaxatives or stool softeners will be documented on the concomitant medication log.

Study Design

Total Participants: 250
Study Start date:
May 01, 2007
Estimated Completion Date:
November 30, 2012

Study Description

OBJECTIVES:

Primary

  • Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as measured by a scored neurologic examination, in young patients undergoing vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.

Secondary

  • Compare the frequency and types of neurotoxicity observed in patients treated with glutamic acid versus placebo.

  • Determine if a greater proportion of patients receiving glutamic acid are able to receive 100% of their scheduled doses of vincristine versus those not treated with glutamic acid.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease and duration of planned vincristine-containing treatment (Wilms' tumor or rhabdomyosarcoma with treatment planned for ≥ 9 consecutive weeks [stratum 1] vs acute lymphoblastic leukemia or non-Hodgkin's lymphoma with treatment planned for ≥ 4 consecutive weeks [stratum 2]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.

  • Arm II: Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) for a total of 4 doses of vincristine or week 10 (stratum 1) for a total of 9 doses of vincristine.

All patients undergo neurologic examination at baseline and at 5 weeks. Patients in stratum 1 also undergo additional neurologic examination at week 10.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Connect with a study center

  • San Jorge Children's Hospital

    Santurce, 00914
    Puerto Rico

    Site Not Available

  • Children's Hospital of Alabama at University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • Mattel Children's Hospital at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307
    United States

    Site Not Available

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Nemours Children's Clinic

    Jacksonville, Florida 32207-8482
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida 32504
    United States

    Site Not Available

  • All Children's Hospital

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • CCOP - Florida Pediatric

    Tampa, Florida 33682-7757
    United States

    Site Not Available

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • Blank Children's Hospital

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan 49503-2560
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - St. Paul

    Saint Paul, Minnesota 55106-2049
    United States

    Site Not Available

  • Cardinal Glennon Children's Hospital

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • SUNY Upstate Medical University Hospital

    Syracuse, New York 13210
    United States

    Site Not Available

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina 28232-2861
    United States

    Site Not Available

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157-1081
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205-2696
    United States

    Site Not Available

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon 97227
    United States

    Site Not Available

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • CHRISTUS Santa Rosa Children's Hospital

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Scott and White Cancer Institute

    Temple, Texas 76508
    United States

    Site Not Available

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin 54307-9070
    United States

    Site Not Available

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