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

November 19, 2014 updated by: Eric Bouffet, The Hospital for Sick Children

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Ontario Cancer Research Network

Investigators

  • Principal Investigator: Eric Bouffet, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0020010429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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