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NCT00369564 · ClinicalTrials.gov registry record · Phase 3
Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer
A Phase 3 study of Lymphoma and Leukemia, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 6
- Study locations
NCT00369564: Completed Phase 3 study of Lymphoma and Leukemia, sponsored by University of South Florida.
NCT00369564 is a Phase 3 study of Lymphoma and Leukemia that has completed, run by University of South Florida. The registered enrollment target is 250 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (48% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369564, a Phase 3 study of Lymphoma and Leukemia, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified "Balis" Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportio
Conditions Studied
Interventions
- OTHER placebo
- DRUG glutamic acid
Study Locations (6)
Florida
- Lee Cancer Care of Lee Memorial Health System - Fort Myers
Michigan
- Butterworth Hospital at Spectrum Health - Grand Rapids
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis - Minneapolis
New Jersey
- Hackensack University Medical Center Cancer Center - Hackensack
North Carolina
- Blumenthal Cancer Center at Carolinas Medical Center - Charlotte
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT00369564 record still lists
NCT00369564 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (48% lower).
The record links to 6 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00369564 lists 6 locations in 6 states (Florida, Michigan, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00369564 about?
NCT00369564 is a clinical study titled "Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer". 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-Hod...
What is the current status of trial NCT00369564?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2007-05. Estimated completion is 2012-11.
What conditions does trial NCT00369564 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Sarcoma, Kidney Cancer, Peripheral Neuropathy.
What interventions are being tested in trial NCT00369564?
The interventions under investigation include: placebo (OTHER), glutamic acid (DRUG).
Who is sponsoring clinical trial NCT00369564?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00369564 being conducted?
This trial has 6 study locations across Florida, Michigan, Minnesota, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00369564's enrollment target sits among peer trials
250 43rd of 299 higher than 256 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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