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


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Glioma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the response rate to Vinblastine in recurrent low grade glioma of childhood

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

Eric Bouffet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children, Toronto Canada

Authority:

Canada: Health Canada

Study ID:

0020010429

NCT ID:

NCT00213278

Start Date:

January 2002

Completion Date:

February 2013

Related Keywords:

  • Glioma
  • glioma
  • brain tumour
  • cancer
  • pediatrics
  • vinblastine sulfate
  • Glioma

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