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

NCT ID: NCT01688401

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-08
• Study Completion Date: 2018-11-26

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.

Conditions

Diffuse Intrinsic Pontine Glioma (DIPG)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IA melphalan

IA melphalan is administered via the basilar artery.

Group Type: EXPERIMENTAL

Melphalan hydrochloride

Intervention Type: DRUG

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.

Interventions

Melphalan hydrochloride

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.

Intervention Type: DRUG

Other Intervention Names

Alkeran

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Solving Kids' Cancer

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Pearl, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00069122

Identifier Type: OTHER

Identifier Source: secondary_id

J11164

Identifier Type: -

Identifier Source: org_study_id