Status:
COMPLETED
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Ontario Cancer Research Network
Conditions:
Glioma
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- \< 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00213278
Start Date
January 1 2002
End Date
September 1 2012
Last Update
November 20 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8