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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 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.

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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.

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

FieldValue
Enrollment Target 250 participants
Start Date 2007-05
Est. Completion 2012-11
Phase Phase 3

Sponsor

University of South Florida

252 total trials

What the Registry Record Tells You About NCT00369564

The ClinicalTrials.gov registry entry for NCT00369564 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (48% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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