Phase 2
N=49
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
Kidney Cancer · Leukemia · Lymphoma · Neurotoxicity · Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00365768 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Incidence of Vincristine-induced Peripheral Neuropathy — 24; 25 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Glutamine (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Vincristine-induced Peripheral Neuropathy |
24; 25 | — |
| SECONDARY Number of Participants With Progression of Neuropathy |
11; 19 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00365768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.