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

The Hospital for Sick Children

Status and phase

Completed

Phase 2

Conditions

Glioma

Treatments

Drug: vinblastine sulphate injection

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

0020010429

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

1 day to 21 years old

Volunteers

No Healthy Volunteers

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