CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
glutamic acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00369564
NCT00369564Phase 3Completed
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Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer

University of South Florida·interventional·Posted Aug 29, 2006·Updated Aug 11, 2021

In Brief

A Phase 3 clinical trial evaluating glutamic acid and placebo for Kidney Cancer and 5 related conditions. Completed, enrolled 250 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Children's Oncology Group

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartMay 1, 2007
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 19.8 years ago

Interventions

glutamic aciddrug

Given orally 3 times daily

placeboother

Given orally 3 times daily