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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma

Intervention / Treatment
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* Drug: Glutamine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: Glutamine<br>Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. | Drug: Glutamine<br>* Administered orally twice daily for 21 days<br>* Other names: Nutritional Supplement;|
| Placebo Comparator: Arm II: Placebo<br>Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. | Other: Placebo<br>* Administered orally twice daily for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Vincristine-induced Peripheral Neuropathy |  | Up to 30 weeks from baseline while on Vincristine treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Progression of Neuropathy |  | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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