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

Johns Hopkins Medicine

Status and phase

Completed

Phase 1

Conditions

Diffuse Intrinsic Pontine Glioma (DIPG)

Treatments

Drug: Melphalan hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT01688401

J11164

NA_00069122 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

1 month to 17 years old

Volunteers

No Healthy Volunteers

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.