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Clinical Trials Information

The Mycosis Fungoides Forum will feature more information about clinical trials in future issues. Clinical trials are studies to determine whether a medication is safe to use and effective in a particular disease. There are specific guidelines as to who may and who may not participate according to the protocol of the study. Additional information about these three trials can be obtained on the Internet at: http://www.centerwatch.com or from the contact persons listed. The first two trials will be offered at additional sites. Watch for this information to be posted on CenterWatch.

Data obtained from clinical trials provides information for physicians to determine more effective ways to treat patients. Results of research may also help get new drugs approved by the Federal Drug Administration (FDA) and provide additional treatment options for patients. Clinical trials contribute to knowledge and progress in our mission to find better treatments. If you are interested in the possibility of participating in a clinical trial, discuss this with your physician.

Trial Summary: A study for patients who have stage IB -- IIA cutaneous T-cell lymphoma (CTCL)

This is an open-label, dose-randomized study of Targretin® capsules (patients will receive one of two doses of Targretin®) in combination with PUVA therapy in patients with stage IB - IIA cutaneous T-cell lymphoma. Both Targretin® and PUVA therapy have been approved by the FDA for treatment in patients with cutaneous T-cell lymphoma. This study will compare the efficacy and safety of the two doses of Targretin®, each in combination with PUVA therapy, with the goal of maximizing patient response.

Trial offered in Chicago, IL, Tyler, TX, and Olympia, WA.

For further information, please contact:

Humaira Serajuddin Millennix Inc.
3020 Westchester Ave., Suite 202
Purchase, NY 10577
Telephone: 914-694-4949
email: hserajuddin@millennix-inc.com

Trial Summary: This phase II research study will determine the response rate and toxicity associated with interleukin-2 (IL-2) therapy given as subcutaneous injections in patients with mycosis fungoides (MF) or the Sézary syndrome (SS).

Patients will self-administer the investigational drug, Proleukin (recombinant IL-2) for four consecutive days, preferably Monday through Thursday, followed by a two-week resting period with no injections. The investigational drug will be given every eight weeks as tolerated by the patient and continue for two cycles past best response. Patients demonstrating a persistent partial response may continue on the investigational drug as tolerated until there is evidence of progressive disease.

Trial offered in Boston, MA.

For further information, please contact:

Tracy Bell, R.N., M.S.N., Research Coordinator
Cancer Clinical Trials Office
New England Medical Center
750 Washington Street, NEMC #245
Boston, MA 02111
Telephone: 617-636-5558
Fax: 617-636-1316
email: TBell@Lifespan.org

Trial Summary: Transimmunization is a new procedure for greater than stage 1A cutaneous T-cell lymphoma (CTCL) patients, that more efficiently brings denditric cells in contact with cancer cells to stimulate an anti-tumor immune response.

Patients must be 18 or more years of age; have a histologic confirmed diagnosis of CTCL; be at a clinical stage greater than 1A; and be able to tolerate intravenous fluid shifts. Treatments are given in an outpatient setting on three consecutive days (approximately three hours per day), repeated monthly for three months. Previous or current treatment with Extracorporeal photochemotherapy (ECP), or photopheresis, does not make a patient ineligible for the study.

Trial offered in Connecticut.

For further information, please contact:

Inger Christensen, R.N.
Department of Dermatology
Yale University School of Medicine
Telephone: 203-688-6445
e-mail: inger.christensen@yale.edu