Name of the Trial
Phase I Study of Enzastaurin in Patients with Recurrent Gliomas (NCI-05-C-0136). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0136.

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 death). 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 dose, 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."

Who Can Join This Trial
Researchers will recruit approximately 42 patients aged 18 or over with a confirmed diagnosis of malignant glioma that has recurred despite previous radiation treatment with or without prior chemotherapy and that is progressing. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-05-C-0136.

Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more information about this trial, call a Neuro-Oncology Branch Patient Care Coordinator at 301-402-6298 or the NCI Clinical Studies Support Center toll free at 1-888-NCI-1937. This call is completely confidential.