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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Vincristine

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.