Name of the Trial
Phase II Study of FR901228 (Depsipeptide) in Patients with Cutaneous T-Cell Lymphoma, Relapsed Peripheral T-Cell Lymphoma, or Other Mature T-Cell Lymphoma (NCI-01-C-0049). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-01-C-0049.

Principal Investigators
Dr. Susan E. Bates and Dr. Richard Piekarz, NCI Center for Cancer Research

Why This Trial Is Important
Principal investigators for this phase II trial, which was first featured in the January 13, 2004, issue of the NCI Cancer Bulletin, are seeking additional patients with cutaneous T-cell lymphoma to form a new study population, or cohort.

"Because of the promising responses we've seen in the first cohort of this study, we've opened a new cohort specifically for patients with cutaneous T-cell lymphoma who have had two or fewer prior chemotherapy regimens," said Dr. Piekarz.

With this trial, researchers are seeking to determine whether romidepsin (FR901228, depsipeptide), a histone deacetylase inhibitor, can help bring about remission in patients with T-cell lymphoma.

"This trial is very exciting because it involves a new class of anticancer drugs that can change the way cells grow," said Dr. Bates. "Whereas many chemotherapy drugs work by causing damage to cells, histone deacetylase inhibitors like romidepsin turn on genes in cancer cells that inhibit cell growth and eventually cause the cancer cells to die."

"We are continuing to see a complete or partial response rate between 30 and 40 percent for patients with cutaneous T-cell lymphoma," Dr. Piekarz said. "And the response rate for patients with peripheral T-cell lymphoma has remained steady at 25 percent."

Who Can Join This Trial
Researchers seek to enroll a total of 197 patients aged 18 and over who have cutaneous T-cell lymphoma, peripheral T-cell lymphoma, or other mature T-cell lymphomas. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/NCI-01-C-0049. 

Study Sites and Contact Information
Multiple study sites are enrolling patients in this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/NCI-01-C-0049 or call NCI's Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937). The call is toll free and completely confidential.