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Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer [ACCL0731]

This study is currently Recruiting

May 2011 By National Cancer Institute (NCI)

First Recieved on August 24, 2006

Last Updated on May 3, 2011

Sponsor: University of Florida
Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00369564

Purpose

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.

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

Eligibility

Ages Eligible for Study:3 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

DISEASE CHARACTERISTICS: - Undergoing vincristine-containing treatment for any of the following newly diagnosed malignancies: - Wilms' tumor or rhabdomyosarcoma - Scheduled to receive ? 9 consecutive weeks of vincristine-containing chemotherapy regimen - Acute lymphoblastic leukemia or non-Hodgkin's lymphoma - Scheduled to receive ? 4 consecutive weeks of vincristine-containing chemotherapy regimen and concurrent steroid therapy - No underlying neuromuscular disease or peripheral neuropathy - Normal baseline peripheral neurologic exam - No primary intracranial malignancy PATIENT CHARACTERISTICS: - No seizure disorders - No family history of Charcot-Marie-Tooth disease - No recent history of Guillain-Barre syndrome PRIOR CONCURRENT THERAPY: - No concurrent itraconazole - No regular use of laxatives or stool softeners prophylactically for constipation prior to chemotherapy - No concurrent enrollment on another investigational protocol involving a study agent that is provided under an IND

Investigators

  • Investigator: Scott Bradfield, MD - Study Chair - Nemours Children's Clinic
  • Investigator: Eric Sandler, MD - - Nemours Children's Clinic
  • Investigator: David R. Freyer, DO, MS - Study Chair - Wake Forest University

Locations

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

    Birmingham, Alabama 35233 United States

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

    Long Beach, California 90806 United States

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027-6016 United States

  • Mattel Children's Hospital at UCLA

    Los Angeles, California 90095 United States

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware 19803 United States

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307 United States

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida 33901 United States

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908 United States

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021 United States

  • Nemours Children's Clinic

    Jacksonville, Florida 32207-8482 United States

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806 United States

  • Florida Hospital Cancer Institute

    Orlando, Florida 32804 United States

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida 32504 United States

  • All Children's Hospital

    St. Petersburg, Florida 33701 United States

  • St. Joseph's Children's Hospital of Tampa

    Tampa, Florida 33677-4227 United States

  • CCOP - Florida Pediatric

    Tampa, Florida 33682-7757 United States

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

    Atlanta, Georgia 30322 United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826 United States

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

    Boise, Idaho 83712 United States

  • Blank Children's Hospital

    Des Moines, Iowa 50309 United States

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan 49503-2560 United States

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan 49503 United States

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404 United States

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota 55455 United States

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905 United States

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

    Saint Paul, Minnesota 55106-2049 United States

  • Cardinal Glennon Children's Hospital

    Saint Louis, Missouri 63104 United States

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106 United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102-2386 United States

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey 07601 United States

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

    New Brunswick, New Jersey 08901 United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87131 United States

  • SUNY Upstate Medical University Hospital

    Syracuse, New York 13210 United States

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina 28232-2861 United States

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157-1081 United States

  • Nationwide Children's Hospital

    Columbus, Ohio 43205-2696 United States

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

    Portland, Oregon 97227 United States

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania 18017 United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224 United States

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411 United States

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas 76104 United States

  • CHRISTUS Santa Rosa Children's Hospital

    San Antonio, Texas 78207 United States

  • Scott and White Cancer Institute

    Temple, Texas 76508 United States

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin 54307-9070 United States

  • San Jorge Children's Hospital

    Santurce, 00914 Puerto Rico

Conditions related to this trial:

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