Call for Patients!!!!!!! NEW CLINICAL TRIAL!!!!!!!!

Jim

We have powerful new immunotherapy treatments for patients with metastatic melanoma using cell transfer techniques (see attached publication).

Our latest treatment has a 72% objective response rate with 36% complete responses.

We are currently recruiting patients for our latest trial.


Is there some way to post this “Call for Patients” on the web site?

Steve Rosenberg

Steven A. Rosenberg M.D., Ph.D.

Chief, Surgery Branch
National Cancer Institute
10 Center Drive MSC 1201
CRC Room 3-3940
Bethesda, MD 20892

301-496-4164

sar@nih.gov

Adoptive Cell Therapy for Patients With Metastatic Melanoma: Evaluation of Intensive Myeloablative Chemoradiation Preparative Regimens


Mark E. Dudley, James C. Yang, Richard Sherry, Marybeth S. Hughes, Richard Royal, Udai Kammula,
Paul F. Robbins, JianPing Huang, Deborah E. Citrin, Susan F. Leitman, John Wunderlich, Nicholas P. Restifo,
Armen Thomasian, Stephanie G. Downey, Franz O. Smith, Jacob Klapper, Kathleen Morton,
Carolyn Laurencot, Donald E. White, and Steven A. Rosenberg


Purpose
The two approved treatments for patients with metastatic melanoma, interleukin (IL)-2 and dacarbazine, mediate objective response rates of 12% to 15%. We previously reported that adoptive cell therapy (ACT) with autologous antitumor lymphocytes in lymphodepleted hosts mediated objective responses in 51% of 35 patients. Here, we update that study and evaluate the safety and efficacy of two increased-intensity myeloablative lymphodepleting regimens.

Patients and Method

We performed two additional sequential trials of ACT with autologous tumor-infiltrating lymphocytes (TIL) in patients with metastatic melanoma. Increasing intensity of host preparative lymphodepletion consisting of cyclophosphamide and fludarabine with either 2 (25 patients) or 12 Gy (25 patients) of total-body irradiation (TBI) was administered before cell transfer. Objective
response rates by Response Evaluation Criteria in Solid Tumors (RECIST) and survival were evaluated. Immunologic correlates of effective treatment were studied.

Results

Although nonmyeloablative chemotherapy alone showed an objective response rate of 49%,
when 2 or 12 Gy of TBI was added, the response rates were 52% and 72% respectively.
Responses were seen in all visceral sites including brain. There was one treatment-related death in the 93 patients. Host lymphodepletion was associated with increased serum levels of the lymphocyte homeostatic cytokines IL-7 and IL-15. Objective responses were correlated with the telomere length of the transferred cells.


Conclusion

Host lymphodepletion followed by autologous TIL transfer and IL-2 results in objective responserates of 50% to 70% in patients with metastatic melanoma refractory to standard therapies.

J Clin Oncol 26:5233-5239. Published by the American Society of Clinical Oncology

The paper is upload in my shared files : (see Shared Files)

Dudley JCO '08 Adoptive Cell Therapy for Patients With Metastatic