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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213278

Enrollment

Registered

2005-09-21

Start date

2002-01-31

Completion date

2012-09-30

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Keywords

glioma, brain tumour, cancer, pediatrics, vinblastine sulfate

Brief 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.

Interventions

DRUGvinblastine 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood	52 weeks

Secondary

Measure	Time frame
To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine	52 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026