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NCT Number: NCT00365768

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

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.

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Key information

Conditions

Kidney Cancer Burkitt Lymphoma Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Kidney Diseases Kidney Neoplasms Leukemia Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Extranodal NK-T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Nervous System Diseases Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuromuscular Diseases Neurotoxicity Neurotoxicity Syndromes Peripheral Nervous System Diseases Peripheral Neuropathy Poisoning Sarcoma Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases Wilms Tumor

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glutamine

Drug

Administered orally twice daily for 21 days

Other names: Nutritional Supplement

Placebo

Other

Administered orally twice daily for 21 days

Primary outcomes

  1. Incidence of Vincristine-induced Peripheral Neuropathy

    Time frame: Up to 30 weeks from baseline while on Vincristine treatment

Secondary outcomes

  1. Number of Participants With Progression of Neuropathy

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2006
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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