Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.

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

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Ontario Cancer Research Network
• Treatments: Vinblastine

Criteria

Inclusion Criteria:

• < 21 years of age at original diagnosis

• histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis

• evidence of tumor recurrence or progression by MRI or contrast CT

• Karnofsky and Lansky performance status of 0,1 or 2

• life expectancy of greater than or equal to 2 months

• adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine

• absolute neutrophil count (ANC)> 1000/uL

• platelet count > 100,000/uL (transfusion independent)

• serum creatinine < 1.5 x normal for age

• written informed consent signed by subject and/or subject's parent/legal guardian

Exclusion Criteria:

• not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy

• chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)

• less than 7 days since the completion of therapy with a biologic agent

• less than 2 months since cranial/spinal radiation

• receiving a stable dose of dexamethasone for less than one week