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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia Glade Bender, Columbia University
ClinicalTrials.gov Identifier:
NCT00365768
First received: August 16, 2006
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Leukemia
Lymphoma
Neurotoxicity
Peripheral Neuropathy
Sarcoma
Drug: Glutamine
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Incidence of vincristine-induced peripheral neuropathy [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neurological status as measured by neuropsychological assessment, clinical neurological examination, and serum markers [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Quality of life (QOL) as measured by the Pediatric Cancer QOL Inventory [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: October 2004
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I: Glutamine
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Drug: Glutamine
Administered orally twice daily for 21 days
Other Name: Nutritional Supplement
Placebo Comparator: Arm II
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Other: Placebo
Administered orally twice daily for 21 days

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.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365768

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Julia L. Glade-Bender, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Julia Glade Bender, Irving Assistant Professor of Clinical Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT00365768     History of Changes
Other Study ID Numbers: AAAA6806, CPMC-ICCR-3349
Study First Received: August 16, 2006
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage II childhood small noncleaved cell lymphoma
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
childhood grade III lymphomatoid granulomatosis
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
stage I childhood large cell lymphoma
stage I childhood lymphoblastic lymphoma
stage I childhood small noncleaved cell lymphoma
stage II childhood large cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
stage IV childhood lymphoblastic lymphoma
stage IV childhood small noncleaved cell lymphoma
childhood Burkitt lymphoma
stage III childhood small noncleaved cell lymphoma
untreated childhood acute lymphoblastic leukemia
childhood nasal type extranodal NK/T-cell lymphoma
previously untreated childhood rhabdomyosarcoma
localized Ewing sarcoma/PNET
metastatic Ewing sarcoma/PNET
neurotoxicity
peripheral neuropathy

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Lymphoma
Peripheral Nervous System Diseases
Lymphoma, Non-Hodgkin
Neurotoxicity Syndromes
Sarcoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Neoplasms, Connective and Soft Tissue
Vincristine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014