Clinical trial NCT00365768: Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Official title: A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Leukemia
Lymphoma
Neurotoxicity
Peripheral Neuropathy
Sarcoma
Keywords: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Vincristine-induced Peripheral Neuropathy
timeFrame: Up to 30 weeks from baseline while on Vincristine treatment
Secondary outcomes:
measure: Number of Participants With Progression of Neuropathy
timeFrame: 42 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Julia L. Glade-Bender, MD
role: PRINCIPAL_INVESTIGATOR
References: