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Trial record 29 of 33 for:    "Ewing Sarcoma" | "Vincristine"

Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

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ClinicalTrials.gov Identifier: NCT00365768
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Julia Glade Bender, Columbia University

Tracking Information
First Submitted Date  ICMJE August 16, 2006
First Posted Date  ICMJE August 17, 2006
Results First Submitted Date  ICMJE November 6, 2015
Results First Posted Date  ICMJE September 9, 2016
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE October 2004
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Incidence of Vincristine-induced Peripheral Neuropathy [ Time Frame: Up to 30 weeks from baseline while on Vincristine treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00365768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Number of Participants With Progression of Neuropathy [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Official Title  ICMJE A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Neurotoxicity
  • Peripheral Neuropathy
  • Sarcoma
Intervention  ICMJE
  • Drug: Glutamine
    Administered orally twice daily for 21 days
    Other Name: Nutritional Supplement
  • Other: Placebo
    Administered orally twice daily for 21 days
Study Arms  ICMJE
  • Experimental: Arm I: Glutamine
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
    Intervention: Drug: Glutamine
  • Placebo Comparator: Arm II: Placebo
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)
56
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients between the age of 5 and 21 years old.
  • Patients who demonstrate the ability to complete the assessment instruments at baseline.
  • Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of > or = to 6mg/m2 of vincristine, or > 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.

Exclusion Criteria:

  • Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
  • Patients with recurrent disease.
  • Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
  • Patients who have already received > 8mg/m2 of vincristine, or > 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
  • Patients with hepatic encephalopathy or hyperammonemia.
  • Patients with a focally abnormal neurologic exam.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00365768
Other Study ID Numbers  ICMJE AAAA6806
CPMC-ICCR-3349 ( Other Identifier: Columbia University Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Julia Glade Bender, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julia L. Glade-Bender, MD Herbert Irving Comprehensive Cancer Center
PRS Account Columbia University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP