Protocol

SJHG12: Phase I Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants with Diffuse Intrinsic Pontine Glioma and High-Grade Glioma

Diseases

Brain Tumor : Progressive or recurrent pontine glioma or high-grade glioma

Description

This is a phase I study of a combination of two new oral medications called crizotinib and dasatinib. These drugs will be used to treat a malignant brain or spinal cord cancer called either a diffuse intrinsic pontine glioma (DIPG) or a high-grade glioma (HGG). Both types of cancers are very difficult to treat. Crizotinib and dasatinib are commercially-available medications approved for the treatment of lung cancer and leukemia in adults. Both medications are thought to block specific proteins in the body that cause cancer to grow and spread. The vast majority of children and adolescents with DIPG and HGG cannot be cured with current available treatments. Therefore, new treatment options are needed for these patients. 

Two groups of participants with DIPG and HGG will be treated on this study. One group (Stratum A) consists of participants whose tumors have grown after initial treatment. The second group (Stratum B) consists of participants with newly diagnosed DIPG or HGG who have received initial treatment, including radiation, before enrolling on this study and the tumor has not grown. Participants in stratum A will receive the study medication first. Participants in stratum B will only be candidates for this study once one the doses of the study of the study medications if found to be safe in stratum A. At first, we will find the highest safe dose of the study medications for participants with progressive (advanced) or recurrent (came back) tumors (stratum A). After that, we will find the highest dose of the study medications for participants who have not had tumor growth (stratum B).


Objectives


Eligibility Criteria, among others, include:


Contact

Alberto Broniscer, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 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.