Status:
COMPLETED
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Lead Sponsor:
Columbia University
Conditions:
Kidney Cancer
Leukemia
Eligibility:
All Genders
5-21 years
Phase:
PHASE2
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: T...
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 glutami...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00365768
Start Date
October 1 2004
End Date
June 1 2012
Last Update
September 9 2016
Active Locations (1)
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1
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032