Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG).
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 3/30/2019 |
| Start Date: | March 8, 2013 |
| End Date: | November 26, 2018 |
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.
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.
the complications and adverse events associated with toxicity from systemic chemotherapy.
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.
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