Clinical Trial: Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Brief Summary:

Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.

This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.


Detailed Summary:
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome:

  • To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
  • To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
  • To determine the toxicity of this drug regimen.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
  • To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.


Original Secondary Outcome: Same as current

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: September 12, 2005
Date Started: December 1999
Date Completion:
Last Updated: June 22, 2011
Last Verified: June 2011