Diffuse Intrinsic Pontine Glioma (DIPG)
Conditions
Keywords
diffuse intrinsic pontine glioma (DIPG), intra-arterial chemotherapy, angiography
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.
Interventions
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.
Sponsors
Solving Kids' Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical safety as determined by number of participants with toxicity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Efficacy as assessed by progression free survival | 2 years | Number of months until disease progression. |
Other
| Measure | 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 |
| 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 |
Countries
United States
Outcome results
None listed