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

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ClinicalTrials.gov Identifier: NCT00213278
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 20, 2014
Ontario Cancer Research Network
Information provided by (Responsible Party):
Eric Bouffet, The Hospital for Sick Children

September 13, 2005
September 21, 2005
November 20, 2014
January 2002
September 2011   (Final data collection date for primary outcome measure)
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood [ Time Frame: 52 weeks ]
- tumor response assessed through MRI
Complete list of historical versions of study NCT00213278 on ClinicalTrials.gov Archive Site
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 ]
- serious and related adverse events during treatment
Not Provided
Not Provided
Phase 2 Study of Vinblastine in Children With Recurrent or Refractory Low Grade Glioma
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Experimental: 1
Intervention: Drug: vinblastine sulphate injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Eric Bouffet, The Hospital for Sick Children
The Hospital for Sick Children
Ontario Cancer Research Network
Principal Investigator: Eric Bouffet, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP