Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioma
Intervention: vinblastine sulphate injection (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Eric Bouffet, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
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.
Clinical Details
Official title: A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Secondary outcome: To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information
Starting date: January 2002
Last updated: November 19, 2014
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