Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
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|ClinicalTrials.gov Identifier: NCT01688401|
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Intrinsic Pontine Glioma (DIPG)||Drug: Melphalan hydrochloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).|
|Actual Study Start Date :||March 8, 2013|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 26, 2018|
Experimental: IA melphalan
IA melphalan is administered via the basilar artery.
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.
Other Name: Alkeran
- Technical safety as determined by number of participants with toxicity [ Time Frame: 60 days ]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.
- Long-term Efficacy as assessed by progression free survival [ Time Frame: 2 years ]Number of months until disease progression.
- Immediate Efficacy as assessed by number of participants with decrease in required steroid dose [ Time Frame: 60 days ]
- Immediate Efficacy as assessed by number of participants with decrease in tumor size on MRI [ Time Frame: 60 days ]
- Immediate Efficacy as assessed by number of participants with decrease in the degree of enhancement on MRI [ Time Frame: 60 days ]
- Immediate Efficacy as assessed by number of participants with improved neurological examination [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688401
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Monica Pearl, M.D.||Johns Hopkins University|