Clinical trial · Interventional
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
NCT00213278CI-TRIAL-00016124completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vinblastine sulphate injection | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: vinblastine sulphate injection
Primary outcomes (1)
- measure
- To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
- timeFrame
- 52 weeks
Secondary outcomes (1)
- measure
- To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine
- timeFrame
- 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.