Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
NCT ID: NCT00213278
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2002-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
vinblastine sulphate injection
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.
Interventions
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vinblastine sulphate injection
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
21 Years
ALL
No
Sponsors
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Ontario Cancer Research Network
NETWORK
The Hospital for Sick Children
OTHER
Responsible Party
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Eric Bouffet
Section Head, Neuro-Oncology
Principal Investigators
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Eric Bouffet, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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0020010429
Identifier Type: -
Identifier Source: org_study_id