A Phase 1 interventional study of Melphalan hydrochloride in Diffuse Intrinsic Pontine Glioma (DIPG), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1, Interventional, and Other
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 3 is below the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Documented hypercoagulable disorders or vasculopathies
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.
Also known as: Alkeran
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
Long-term Efficacy as assessed by progression free survival
Number of months until disease progression.
Time frame: 2 years
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
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins