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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 ³.

Principal Investigators

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

Drs. Susan Bates and Richard Piekarz Principal Investigator

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 ⁴ for this trial.

Study Sites and Contact Information

Multiple study sites are enrolling patients in this trial. See the list of study contacts ⁵ or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937). The call is toll free and completely confidential.

Glossary Terms

The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

Any of a group of T-cell non-Hodgkin lymphomas that begins in the skin as an itchy, red rash that can thicken or form a tumor. The most common types are mycosis fungoides and Sézary syndrome.

A substance that causes a chemical change that stops tumor cells from dividing. HDAC inhibitors are being studied in the treatment of cancer. Also called HDAC inhibitor.

A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.

One of a group of aggressive (fast-growing) non-Hodgkin lymphomas that begins in mature T lymphocytes (T cells that have matured in the thymus gland and goes to other lymphatic sites in the body, including lymph nodes, bone marrow, and spleen.) Also called mature T-cell lymphoma.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.