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

Completed · Phase 1

Conditions studied: Diffuse Intrinsic Pontine Glioma (DIPG)

In brief

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.

Key facts

Study ID

NCT01688401

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

3

Starts

2013-03-08

Expected to finish

2018-11-26

Last updated by the study team

2019-03-28

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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