NCT00213278CompletedPhase 2
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
The Hospital for Sick Children1 site in 1 country50 target enrollmentStarted: January 2002Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: vinblastine sulphate injection (Drug)
Outcomes
Primary Outcomes
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Time Frame: 52 weeks
Secondary Outcomes
- To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine(52 weeks)
Investigators
Eric Bouffet
Section Head, Neuro-Oncology
The Hospital for Sick Children
Study Sites (1)
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