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Clinical Trial 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