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Title:
Intra-arterial chemotherapy for the treatment of progressive diffuse intrinsic pontine gliomas (DIPG).
Protocol Number:
J11164
Phase:
Phase I
Physician:
Monica Pearl
Purpose:
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.Delivering the chemotherapeutic agent directly to the tumor via the arterial system transforms the treatment of DIPG from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.
Eligibility:
INCLUSION CRITERIA:1)Pediatric patients of all ages with progressive DIPG.2)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:1)Documented hypercoagulable disorders or vasculopathies:1a)INR value more than a Grade 1 toxicity by CTCAE v 4.0 criteria ( greater than 1 - 1.5 x ULN; greater than 1 - 1.5 times above baseline if on anticoagulation).1b)APTT value more than a Grade 1 toxicity by CTCAE v 4.0 criteria ( greater than ULN - 1.5 x ULN).2)Platelets less than 50 x 103/mm3.3)Absolute neutrophil count less than 500/ mm3.4)Pregnancy.5)Documented severe allergic reaction to IV iodinated contrast, specifically bronchospasm and anaphylaxis.
Treatment:
DRUG: Melphalan hydrochlorideDrug administered intra-arterially (injection in the artery).STANDARD DOSE: 1mg Cycle 1, if well tolerated increase dose to 2mg Cycle 2.FREQUENCY: Eight weeks total - two cycles of IA chemotherapy, separated by four weeks.
Population:
Pediatric
Last Update
09/02/2014 04:02 AM
 

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