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

Diffuse Intrinsic Pontine Glioma (DIPG) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688401
• Other study ID #: J11164
• Secondary ID: NA_00069122
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2013
• Est. completion date: November 26, 2018

Study information

• Verified date: March 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 26, 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Intrinsic Pontine Glioma (DIPG)
• Glioma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Solving Kids’ Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immediate Efficacy as assessed by number of participants with decrease in required steroid dose		60 days
Other	Immediate Efficacy as assessed by number of participants with decrease in tumor size on MRI		60 days
Other	Immediate Efficacy as assessed by number of participants with decrease in the degree of enhancement on MRI		60 days
Other	Immediate Efficacy as assessed by number of participants with improved neurological examination		60 days
Primary	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.	60 days
Secondary	Long-term Efficacy as assessed by progression free survival	Number of months until disease progression.	2 years