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Research
Brain Tumor : Newly diagnosed diffuse Intrinsic Pontine glioma and recurrent / progressive high grade glioma including diffuse intrinsic pontine glioma
This clinical research study is evaluating the highest safe dose of a new, highly selective inhibitor of Platelet-derived growth factor receptor (PDGFR) in pediatric and young adult patients with high grade gliomas. Stratum A is open for patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) that have not received prior radiation or chemotherapy; and Stratum B is for patients who have been diagnosed with a high-grade glioma (including DIPG) who have received radiation and chemotherapy previously but the tumors have continued to grow or returned despite this prior therapy.
High grade gliomas of the brainstem and other areas are very difficult to treat as it is not possible to surgically remove all of the tumor cells, and they can grow quickly and spread to other areas of the brain. On this Phase I study, participants with newly diagnosed tumors will receive crenolanib in combination with radiation therapy to the tumor and will continue with crenolanib after completion of radiation, and those patients on Stratum B with progressive or recurrent high grade gliomas will receive crenolanib alone, without radiation therapy.
This is a phase I study of an investigational drug called crenolanib (also called CP-868,596). Investigational means that crenolanib is not approved by the Food and Drug Administration (FDA) for general use, is still being tested in different tumor types and is only available through clinical trials. Crenolanib blocks signaling through the PDGFR on the cell surface.
This receptor and pathway are of great interest in this tumor type because PDGF pathway has been found to be the most commonly activated genetic pathway in tissue samples of DIPG and pediatric high grade gliomas that have been studied to date. PDGF pathway activation also plays an important role in new blood vessel formation.
The rationale for this study is to try to inhibit tumor cell growth and also ‘starve’ the tumor of nutrients by limiting new blood vessel growth. At this point is it not yet known if anindividual patient’s brain tumor depends on PDGF pathway activity to grow or if inhibition of this pathway will stop it from growing, but those are two questions that this trial will also be addressing.
Cynthia Wetmore, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
901-595-2544 or 901-595-4599
FAX: 901-595-5353
Or
Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.
