NCT00369564

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

Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 3 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Cancer
• Leukemia
• Lymphoma
• Neurotoxicity
• Peripheral Neuropathy
• Sarcoma

Interventions

Type	Name	Description
DRUG	glutamic acid	Given orally 3 times daily
OTHER	placebo	Given orally 3 times daily

Timeline

• Start date: 2007-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2006-08-29
• Last updated: 2021-08-11
• Results posted: 2014-03-14

Locations

6 sites across 1 country: United States