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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins3 enrolled

Overview

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 avoids the complications and adverse events associated with toxicity from systemic chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diffuse Intrinsic Pontine Glioma (DIPG)

Interventions

Melphalan hydrochlorideDRUG

Drug administered intra-arterially (injection in the artery). Standard dose: Cycle 1: 1 mg, intra-arterial (IA) delivery. Cycle 2: 2 mg, intra-arterial (IA) delivery. Duration of treatment: Eight weeks total - two cycles of IA chemotherapy, separated by four weeks.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Technical safety as determined by number of participants with toxicity

Number of participants with grades 3-5 intracranial hemorrhage, grades 3-5 stroke, as defined by the Nervous system disorder CTCAE, and requirement of blood transfusion.

Time frame: 60 days

Secondary Outcomes

Long-term Efficacy as assessed by progression free survival

Number of months until disease progression.

Time frame: 2 years

Data from ClinicalTrials.gov

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