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

Phase 2

Completed

• Conditions: Glioma
• Interventions: Drug: vinblastine sulphate injection

• Registration Number: NCT00213278
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2011-09
• Study Completion: 2012-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	vinblastine sulphate injection	-

Primary Outcome Measures

Name	Time	Method
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood	52 weeks

Secondary Outcome Measures

Name	Time	Method
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine	52 weeks

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada