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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213278
• Other study ID #: 0020010429
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 19, 2014
• Start date: January 2002
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Ontario Cancer Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate to Vinblastine in recurrent low grade glioma of childhood		52 weeks	No
Secondary	To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine		52 weeks	No