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| Sponsored by: |
Herbert Irving Comprehensive Cancer Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00365768 |
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 |
|---|---|---|
|
Cancer-Related Problem/Condition Kidney Cancer Leukemia Lymphoma Sarcoma |
Dietary Supplement: glutamine Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
|
Dietary Supplement: glutamine
Given orally
|
|
Arm II: Placebo Comparator
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
|
Other: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
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 |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
Must have documented, clinically mild peripheral neuropathy identified by 1 of the following criteria:
Clinically progressive neuropsychological findings as determined by neuropsychological examination and defined by the following:
At least ½ standard deviation from the baseline score on any of the following 3 neuropsychological instruments that measure both fine and gross motor functioning:
Currently receiving an expected cumulative dose of ≥ 15 mg/m^2 of vincristine over a 30-week period
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| Principal Investigator: | Julia L. Glade-Bender, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000492841, CPMC-AAAA6806, CPMC-ICCR-3349 |
| Study First Received: | August 16, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00365768 History of Changes |
| Health Authority: | Unspecified |
|
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 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/peripheral primitive neuroectodermal tumor metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor neurotoxicity |
|
Neuroectodermal Tumors, Primitive Neurotoxicity Syndromes Urogenital Neoplasms Urologic Neoplasms Neoplasms, Connective and Soft Tissue Wilms' Tumor Neuroepithelioma Kidney Diseases Rhabdomyosarcoma Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Vincristine Ewing's Sarcoma Carcinoma |
Neuroectodermal Tumors Malignant Mesenchymal Tumor Sarcoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Acute Lymphoblastic Leukemia, Childhood Urinary Tract Neoplasm Leukemia, Lymphoid Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Leukemia Sarcoma, Ewing's Soft Tissue Sarcomas Renal Cancer Urologic Diseases |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Urologic Neoplasms Leukemia Neoplasms, Connective and Soft Tissue Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Kidney Diseases Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases |
Mitosis Modulators Vincristine Antimitotic Agents Pharmacologic Actions Carcinoma Lymphatic Diseases Neoplasms Tubulin Modulators Sarcoma Carcinoma, Renal Cell Adenocarcinoma Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
