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