Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Ontario Cancer Research Network
Information provided by (Responsible Party):
Eric Bouffet, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213278
First received: September 13, 2005
Last updated: November 19, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: November 19, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 25, 2014