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

Primary Purpose

Glioma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
vinblastine sulphate injection
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring glioma, brain tumour, cancer, pediatrics, vinblastine sulfate

Eligibility Criteria

1 Day - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To determine the response rate to Vinblastine in recurrent low grade glioma of childhood

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
November 19, 2014
Sponsor
The Hospital for Sick Children
Collaborators
Ontario Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00213278
Brief Title
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
Official Title
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Ontario Cancer Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
glioma, brain tumour, cancer, pediatrics, vinblastine sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vinblastine sulphate injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bouffet, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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