Name of the Trial
Phase I Study of CC8490 in Patients with Recurrent or Refractory High-Grade Gliomas (NCI-04-C-0035). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0035.

Principal Investigator
Dr. Howard A. Fine, Neuro-Oncology Branch, NCI CCR

Why Is This Trial Important?
Malignant gliomas are the most common type of primary malignant brain tumor found in adults. Currently, there are no effective treatments for malignant gliomas that progress or recur following initial treatment.

In this phase I trial, researchers are testing a new drug called CC8490 in patients with progressive or recurrent malignant gliomas. In preclinical studies, CC8490 inhibited the growth of glioma cells and induced glioma cell death. This trial will determine the maximum dose of CC8490 that can be given to patients and will assess the safety and tolerability of this drug. Additionally, researchers hope to determine the mechanism by which CC8490 affects glioma cells.

"Years ago, doctors observed that the antiestrogen drug tamoxifen occasionally causes regression of glioma tumors, even though those tumors do not possess estrogen receptors," said Dr. Fine. "Consequently, NCI screened many compounds called selective estrogen receptor modulators (SERMs) that had tamoxifen-like activity. CC8490 is one SERM that showed very strong antiglioma activity.

"With this trial, we are trying to determine the highest dose we can give to patients so that we can maximize the antitumor effect of the treatment," Dr. Fine said. "So far, we have initiated five dose escalations and the drug appears to be very well tolerated.

"We think CC8490 may represent a potentially promising new approach to treatment of recurrent malignant glioma."

Who Can Join This Trial?
Researchers seek to enroll up to 34 patients aged 18 or older with malignant gliomas that have either not responded to previous treatment or recurred following previous treatment. See the full list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0035.

Where Is This Trial Taking Place?
The study is taking place at the National Institutes of Health (NIH) Clinical Center in Bethesda, Md.

Contact Information
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.