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

In order for our site to display correctly you will need a newer version of your web browser.

Currently we test and support the following browsers:

FireFox version 3.0 and above (Windows and Mac)
Safari version 5.0 and above (Windows and Mac)
Internet Explorer version 7.0 and above (Windows)

Please note that this is not intended to be an exhaustive list of browsers that support web standards, nor a test of browser compliance, nor a side-by-side comparison of various manufacturers’ browsers.

Research

Back to Current Clinical Trials

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

To find the highest dose of the combination of crizotinib and dasatinib that can be safely given to children with DIPG and HGG
To learn more about how the body of a child takes up, breaks down, and gets rid of crizotinib given alone or in combination with dasatinib
To do blood tests that may prove that the medications are having the desired effects of their target proteins
To find out if the analysis of leftover tumor from previous surgeries (when available)may help predict the tumor response to this treatment
To find out if special magnetic resonance imaging (MRI) scans and a special type of CAT scan called MET PET can help predict the tumor response to this treatment
To learn more about the side effects of these two medications given together over time in children
To learn more about the amount of the study medications that may reach the spinal fluid only in children who may need to have spinal fluid collected for other clinical purposes or where the spinal fluid can be easily collected
To learn more about how the genetic makeup of each child may influence how his/her body takes up and gets rid of the study medications
To learn more about the quality of life of children with DIPG and HGG and their parents during the research study
To learn more about the social and spiritual wellbeing of children with these types of cancers and their parents during the research study

Eligibility Criteria, among others, include:

Participant has a diagnosis of high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).
Participant is > 2 years and < 22 years of age at the time of enrollment.
Participant does not have metastatic disease.

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

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.

Print Email This Article