Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Non-Myeloablative But Lymphocyte Depleting Regimen
Patients with metastatic melanoma who are human immunodeficiency virus (HIV) and Hepatitis B
negative and who have previously progressed after receiving standard therapy will receive a
nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide
and fludarabine and then will be treated by the adoptive transfer of lymphocytes reactive
with shared antigens on their tumors. This study will evaluate the toxicity, immunologic
effects and potential therapeutic role of this treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.
Every three to four weeks after the treatment, for up to 5 years.
Steven Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|