Phase 2 Completed N=49 Randomized Double-blind Supportive Care

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

Kidney Cancer · leukemia · Lymphoma · Neurotoxicity

Source: ClinicalTrials.gov NCT00365768 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2016

Primary outcomePrimary: Incidence of Vincristine-induced Peripheral Neuropathy — 24; 25 participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.