Clinical trial · Interventional
Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
NCT01688401CI-TRIAL-00037837completedPhase 1ClinicalTrials.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)
The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing the local delivered dose while minimizing systemic toxicity. It also provides a treatment option for these patients at the time of tumor recurrence.
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 |
|---|---|---|---|
| Diffuse Intrinsic Pontine Glioma (DIPG) | Diffuse Intrinsic Pontine Glioma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melphalan hydrochloride | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IA melphalan
- description
- IA melphalan is administered via the basilar artery.
- interventionNames
- Drug: Melphalan hydrochloride
Primary outcomes (1)
- measure
- Technical safety as determined by number of participants with toxicity
- timeFrame
- 60 days
- description
- Number of participants with grades 3-5 intracranial hemorrhage, grades 3-5 stroke, as defined by the Nervous system disorder CTCAE, and requirement of blood transfusion.
Secondary outcomes (1)
- measure
- Long-term Efficacy as assessed by progression free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients of all ages with progressive DIPG. * Consensus following presentation of the case at the multidisciplinary Pediatric Neuro-Oncology conference, which includes participation of neuro-oncology, neurosurgery, radiation oncology, interventional neuroradiology and neurology. Exclusion Criteria: * Documented hypercoagulable disorders or vasculopathies * INR value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (\>1 - 1.5 x ULN; \>1 - 1.5 times above baseline if on anticoagulation). * APTT value more than a Grade 1 toxicity by CTCAE v 4.0 criteria (\>ULN - 1.5 x ULN). * Platelets less than 50 x 103/mm3 * Absolute neutrophil count less than 500/ mm3 * Pregnancy * Documented severe allergic reaction to IV iodinated contrast, specifically bronchospasm and anaphylaxis.
References
Publications (0)
Data not yet available
No reference posted for this study.