Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Completed · Phase 2 · Has a placebo group
Conditions studied: Kidney Cancer, Leukemia, Lymphoma, Neurotoxicity, Peripheral Neuropathy, Sarcoma
In brief
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.
Key facts
- Study ID
- NCT00365768
- Run by
- Columbia University
- People needed
- 56
- Starts
- 2004-10-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2016-09-09
Who can join
Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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