IRB Number:

06-002246

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to test the safety of alefecept (Amevive) and see what effects (good and bad) it has on the patient and lymphoma. The study will find the best dose of alefacept (Amevive) that will produce response in the tumor without causing severe side effects. This research is being done so researchers can find better treatments for people with T-cell lymphoma.
This research study is being done by the Lymphoma SPORE (Specialized Program of Research Excellence). The Lymphoma SPORE is a group of 2 health care centers, Mayo Clinic Rochester and the University of Iowa, that have joined together to research lymphoma and lymphoma treatments. For this study, Mayo Clinic Rochester and the University of Iowa are working with other institutions (City of Hope and John Hopkins) who have been awarded SPORE grants from the NCI. The SPORE is supported by the National Cancer Institute. Mayo Clinic Rochester is the coordinating site for the SPORE.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with relapsed or refractory (resistant) Cutaneous T-Cell Lymphoma or Peripheral T-Cell Lymphoma
-No limit on number of prior therapies. Patients with Cutaneous T-Cell Lymphoma should have failed at least 2 skin-directed therapies.

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

-Medical exams
-Blood tests
-Pregnancy test for women potentially able to have children
-Tumor measurement (Physical exam, CT, MRI, photographs, etc.)
-Medication given through a vein

How long will the Study run?

During this study, the patient will get the drug alefacept into a vein once a week for 8 weeks (induction phase). For this study, 1 cycle of treatment equals 4 weeks. After week 8, the disease will be evaluated to see how it is responding to the treatment. If the disease has gotten worse, the patient will receive no additional treatments. If the disease has gotten better or stayed the same, the patient will receive alefacept into a vein once a month for 10 additional cycles (maintenance phase). If the disease gets worse anytime during the maintenance phase, the patient will receive alefacept into a vein once a week for 4 weeks and then start the maintenance phase over. Patients may receive treatment on this study for up to 3 years. The patient's general health may continue to be followed for up to 3 years from the time of starting the study.

Sponsor(s): Lymphoma Spore

Study Activation: 05/09/2006

IRB Review and Approval Date: 03/23/2006

Study Type: Treatment

Projected Accrual: 24 patients

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Thomas Witzig, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/23/2008