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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213278
First Posted: September 21, 2005
Last Update Posted: November 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ontario Cancer Research Network
Information provided by (Responsible Party):
Eric Bouffet, The Hospital for Sick Children
  Purpose
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.

Condition Intervention Phase
Glioma Drug: vinblastine sulphate injection Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma

Resource links provided by NLM:


Further study details as provided by Eric Bouffet, The Hospital for Sick Children:

Primary Outcome Measures:
  • To determine the response rate to Vinblastine in recurrent low grade glioma of childhood [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2002
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213278


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Ontario Cancer Research Network
Investigators
Principal Investigator: Eric Bouffet, MD The Hospital for Sick Children, Toronto Canada
  More Information

Responsible Party: Eric Bouffet, Section Head, Neuro-Oncology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213278     History of Changes
Other Study ID Numbers: 0020010429
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Eric Bouffet, The Hospital for Sick Children:
glioma
brain tumour
cancer
pediatrics
vinblastine sulfate

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action