Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NA_00069122 | Other Identifier | JHMIRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Solving Kids' Cancer | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IA melphalan | Experimental | IA melphalan is administered via the basilar artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan hydrochloride | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Efficacy as assessed by progression free survival | Number of months until disease progression. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Efficacy as assessed by number of participants with decrease in required steroid dose | 60 days | |
| Immediate Efficacy as assessed by number of participants with decrease in tumor size on MRI | 60 days |
Inclusion Criteria:
Exclusion Criteria:
Documented hypercoagulable disorders or vasculopathies
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monica Pearl, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Not provided
| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
Not provided
Not provided
| ID | Term |
|---|---|
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Immediate Efficacy as assessed by number of participants with decrease in the degree of enhancement on MRI | 60 days |
| Immediate Efficacy as assessed by number of participants with improved neurological examination | 60 days |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |