Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
Overview
- Phase
- Phase 1
- Intervention
- Melphalan hydrochloride
- Conditions
- Diffuse Intrinsic Pontine Glioma (DIPG)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Technical safety as determined by number of participants with toxicity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
Delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids the complications and adverse events associated with toxicity from systemic chemotherapy.
Investigators
Eligibility Criteria
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.
Arms & Interventions
IA melphalan
IA melphalan is administered via the basilar artery.
Intervention: Melphalan hydrochloride
Outcomes
Primary Outcomes
Technical safety as determined by number of participants with toxicity
Time Frame: 60 days
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
- Long-term Efficacy as assessed by progression free survival(2 years)