Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).

• Status: Completed
• Trial end date: 2018-11-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Solving Kids' Cancer; Solving Kids’ Cancer
• Treatments: Melphalan

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.