April 2012

November 2007 U.S. clinical trial update

AMN107:

Phase III continues to enroll patients at a rapid rate, according to Novartis. Sites listed in the clinicaltrials. gov database are open with the following exceptions as of October 12: Lee Moffitt in Tampa, FL, MD Anderson in Houston, TX, and New York University, New York, NY. These sites were not yet open. Over 30 other sites are open outside the United States, in Canada, Europe, Australia and Taiwan.

FR901228:

Phase I is suspended.

Oblimersen (Genasense) + Imatinib:

Phase II is no longer accruing patients.

BEZ235:

Phase I for Advanced Solid Tumors is open at the Nevada Cancer Institute in Las Vegas, NV. BEZ235 is a Novartis drug that targets the PI3K tyrosine kinase and indirectly inhibits the downstream targets AKT and mTOR.

Imatinib + Pegylated Interferon-a 2B:

This Phase II trial for GIST is a whole different approach. It is primarily for patients who are newly diagnosed and who have not had Gleevec (or have been off Gleevec for six months or longer). Dr. Lei L. Chen is the primary investigator at the Huntsman Cancer Institute in Salt Lake City, Utah. Dr. Chen theorizes that Gleevec causes GIST cell death which in turn marks GIST cells for immune system response. Interferon will help stimulate that response and aid the immune system in identifying and destroying the remaining GIST stem cells that can cause relapse after Gleevec has shrunk tumors. This trial is planned to have several other innovative aspects that are explained in detail in the May 2007 Newsletter article “Immunotherapy trial strives to improve Gleevec response” by Jerry Call, also available on the LRG website.

Note: Dana-Farber— Travis Quigley, RN, Research Nurse, has indicated that both the Sorafenib (BAY 43-9006) Phase II and the Phase III Sunitinib or Imatinib trial are available there.

To view the latest clinical trials, visit: http://www.liferaftgroup.org/docs/gist_clinical_trial_datasheets.htm