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

Descriptive Information
Brief Title † Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
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 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.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Technical safety
Secondary Outcome Measure † Efficacy
Condition † Diffuse Intrinsic Pontine Glioma (DIPG)
Intervention † DrugMelphalan hydrochloride
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 5
Start Date † January 2013
Completion Date
Primary Completion Date December 2018
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.
Gender All
Ages 1 Month - 17 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01688401
Organization ID J11164
Secondary IDs †† NA_00069122
Responsible Party Sponsor
Study Sponsor † Sidney Kimmel Comprehensive Cancer Center
Collaborators †† Solving Kids’ Cancer
Investigators † Principal Investigator: Monica Pearl, M.D., Johns Hopkins University
Information Provided By
Verification Date March 2017
First Received Date † September 10, 2012
Last Updated Date March 29, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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