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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

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 Summary: Delivering the chemotherapeutic agent directly to the tumor via the arterial system avoids the complications and adverse events associated with toxicity from systemic chemotherapy.
Sponsor: Sidney Kimmel Comprehensive Cancer Center

Current Primary Outcome: Technical safety [ Time Frame: 60 days ]

In this feasibility study, we are going to perform a qualitative evaluation of whether or not we can safely deliver IA chemotherapy to patients with progressive DIPG.

Assessment of non-hematologic toxicity will include grading according to the Nervous system disorder CTCAE, specifically grades 3-5 intracranial hemorrhage and grades 3-5 stroke. Note will be made if the patient requires a blood transfusion.



Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy [ Time Frame: 2 years ]

Analysis of long-term efficacy will be made by assessing progression free survival in terms of months.


Original Secondary Outcome: Same as current

Information By: Sidney Kimmel Comprehensive Cancer Center

Dates:
Date Received: September 10, 2012
Date Started: January 2013
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017