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Chemotherapy for Recurrent Gliomas

Name of the Trial

Phase I Study of Enzastaurin in Patients With Recurrent Gliomas (NCI-05-C-0136). See the protocol summary.

Principal Investigator

Dr. Howard A. Fine
Dr. Howard A. Fine
Principal Investigator

Dr. Howard A. Fine, Neuro-Oncology Branch, NCI Center for Cancer Research.

Why This Trial Is Important

Gliomas are the most common type of primary brain tumor diagnosed in adults. Although they may be treated with surgery, radiation therapy, and chemotherapy, gliomas often come back (recur). The prognosis for patients with recurrent gliomas is very poor.

In this clinical trial, researchers are testing a new drug called enzastaurin in patients whose glioma has recurred after previous radiotherapy and chemotherapy. Enzastaurin is an angiogenesis inhibitor, meaning it prevents tumors from developing the new blood vessels they need for growth. In addition, enzastaurin has been shown to have direct effects on tumor cells, inhibiting their proliferation and stimulating apoptosis (cell suicide). Researchers hope to determine how much enzastaurin patients can receive before developing side effects severe enough to interrupt treatment.

"In a previous trial of enzastaurin for high-grade, recurrent gliomas, we observed very dramatic tumor responses, including some complete responses," Dr. Fine said. "In addition, the drug has been very well tolerated by patients.

"Our research indicates that enzastaurin becomes more toxic to gliomas cells with higher does, so we are conducting this trial to see how much enzastaurin patients can tolerate. We hope to set a dose that will maximize the cytotoxic potential of enzastaurin while maintaining a favorable toxicity profile in preparation for a large, multinational phase III clinical trial."

Contact Information

This study is no longer accepting new patients. To locate other clinical trials for brain cancer, search the NCI database of clinical trials or the NCI Clinical Trials Referral Office toll-free at 1-888-NCI-1937. This call is completely confidential.

  • Posted: February 14, 2006
  • Updated: November 7, 2007