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. This trial was previously featured in the Jan. 13, 2004, issue of the NCI Cancer Bulletin ¹.

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

Why Is This Trial Important?
Principal investigators for this phase II trial are seeking 50 patients with cutaneous T-cell lymphoma to form a new study population, or cohort.

"Because of the promising responses we've seen in 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 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 turn on genes that inhibit cell growth and eventually cause the cancer cells to die."

"We are continuing to see a steady response rate of about 50 percent for patients with cutaneous T-cell lymphoma," Dr. Piekarz said.

Who Can Join This Trial?
Researchers seek to enroll an additional 50 patients aged 18 and over who have cutaneous T-cell lymphoma. Additionally, the trial remains open to patients with peripheral T-cell lymphoma. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/NCI-01-C-0049.

Where Is This Trial Taking Place?
Multiple study sites are enrolling patients in this trial. See the list of study sites at http://cancer.gov/clinicaltrials/NCI-01-C-0049.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/NCI-01-C-0049 or call the NCI's Clinical Studies Support Center (CSSC) at 1-888-NCI-1937 (1-888-624-1937). The call is toll free and completely confidential.