Title
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
Phase
Phase 2Lead Sponsor
University of TorontoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
GliomaIntervention/Treatment
vinblastine ...Study Participants
50This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.
Vinblastine dose: 6 mg/m^2 (10 mg max.) route intravenous administration once a week over a period of 10 weeks. If response at week 10 is greater than or equal to stable, weekly Vinblastine will be continued for 42 weeks.
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
