Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Neurotoxicity as measured by a scored neurologic examination at baseline, 5 weeks, and 10 weeks (if applicable)
10 weeks
Yes
Scott Bradfield, MD
Study Chair
Nemours Children's Clinic
United States: Food and Drug Administration
SCUSF 0402
NCT00369564
May 2007
Name | Location |
---|---|
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |