A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Incidence of vincristine-induced peripheral neuropathy
42 days
Yes
Julia L. Glade-Bender, MD
Principal Investigator
Herbert Irving Comprehensive Cancer Center
United States: Food and Drug Administration
AAAA6806
NCT00365768
October 2004
June 2012
Name | Location |
---|---|
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |