Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT00365768
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2006-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CPMC-ICCR-3349 | OTHER | Columbia University Medical Center | View |