Name of the Trial
Phase II Study of UCN-01 in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell or Mature T-Cell Lymphomas (NCI-04-C-0173). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0173.

Principal Investigator
Dr. Wyndham Wilson, Dr. Keiron Dunleavy (Protocol Co-Chair), and Dr. Alan Wayne (Protocol Co-Chair), NCI Center for Cancer Research.

Why Is This Trial Important?
Lymphomas are cancers of the immune system. There are many different types of lymphoma, and treatment and prognosis depend on the type of lymphoma a patient has and how advanced the cancer has become.

In this trial, researchers are trying to determine whether a new drug called UCN-01 will help kill cancer cells in patients who have a type of lymphoma called anaplastic large cell lymphoma. This type of lymphoma starts in white blood cells called T cells. Anaplastic lymphoma primarily affects children. UCN-01 belongs to a group of drugs called protein kinase inhibitors. Protein kinases are enzymes in cells that help activate or deactivate other proteins, which may play a role in tumor cell growth.

"Protein kinases are like switches that turn other proteins on or off," said Dr. Wilson. "A number of tumor cells have these switches abnormally turned on or off, and this abnormal activity contributes to the survival of the tumor.

"In anaplastic large cell lymphoma, a protein kinase called ALK is turned on all the time. We hope that UCN-01 will inhibit the action of this abnormally activated kinase and cause the tumor cell to enter apoptosis, or programmed cell death.

"We are also interested in seeing if this drug will be useful against other T-cell lymphomas."

Who Can Join This Trial?
Researchers will recruit 18-37 patients aged 9 or over who have been diagnosed with anaplastic large cell lymphoma or mature T-cell lymphoma that has not responded to treatment or has recurred following previously successful treatment. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0173.

Where Is This Trial Taking Place?
The study is taking place at the NIH Clinical Center in Bethesda, Md.

Contact Information
For more information, contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.