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Journal of Clinical Oncology, Vol 23, No 10 (April 1), 2005: pp. 2346-2357
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.00.240
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Adoptive Cell Transfer Therapy Following Non-Myeloablative but Lymphodepleting Chemotherapy for the Treatment of Patients With Refractory Metastatic Melanoma

Mark E. Dudley, John R. Wunderlich, James C. Yang, Richard M. Sherry, Suzanne L. Topalian, Nicholas P. Restifo, Richard E. Royal, Udai Kammula, Don E. White, Sharon A. Mavroukakis, Linda J. Rogers, Gerald J. Gracia, Stephanie A. Jones, David P. Mangiameli, Michelle M. Pelletier, Juan Gea-Banacloche, Michael R. Robinson, David M. Berman, Armando C. Filie, Andrea Abati, Steven A. Rosenberg

From the Surgery Branch; Experimental Immunology and Transplantation Branch; Laboratory of Pathology, Center for Cancer Research, National Cancer Institute; National Eye Institute, National Institutes of Health, Bethesda, MD

Address reprint requests to Steven A. Rosenberg, MD, PhD, Surgery Branch, National Cancer Institute, NIH, CRC 3-3940, 10 Center Dr MSC 1201, Bethesda MD 20892-1202; e-mail: sar{at}mail.nih.gov

PURPOSE: We investigated the combination of lymphodepleting chemotherapy followed by the adoptive transfer of autologous tumor reactive lymphocytes for the treatment of patients with refractory metastatic melanoma.

PATIENTS AND METHODS: Thirty-five patients with metastatic melanoma, all but one with disease refractory to treatment with high-dose interleukin (IL) -2 and many with progressive disease after chemotherapy, underwent lymphodepleting conditioning with two days of cyclophosphamide (60 mg/kg) followed by five days of fludarabine (25 mg/m2). On the day following the final dose of fludarabine, all patients received cell infusion with autologous tumor-reactive, rapidly expanded tumor infiltrating lymphocyte cultures and high-dose IL-2 therapy.

RESULTS: Eighteen (51%) of 35 treated patients experienced objective clinical responses including three ongoing complete responses and 15 partial responses with a mean duration of 11.5 ± 2.2 months. Sites of regression included metastases to lung, liver, lymph nodes, brain, and cutaneous and subcutaneous tissues. Toxicities of treatment included the expected hematologic toxicities of chemotherapy including neutropenia, thrombocytopenia, and lymphopenia, the transient toxicities of high-dose IL-2 therapy, two patients who developed Pneumocystis pneumonia and one patient who developed an Epstein-Barr virus–related lymphoproliferation.

CONCLUSION: Lymphodepleting chemotherapy followed by the transfer of highly avid antitumor lymphocytes can mediate significant tumor regression in heavily pretreated patients with IL-2 refractory metastatic melanoma.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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O. Goldberger, I. Volovitz, A. Machlenkin, E. Vadai, E. Tzehoval, and L. Eisenbach
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A. Worschech, M. Kmieciak, K. L. Knutson, H. D. Bear, A. A. Szalay, E. Wang, F. M. Marincola, and M. H. Manjili
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A. Jorritsma, A. D. Bins, T. N.M. Schumacher, and J. B.A.G. Haanen
Skewing the T-Cell Repertoire by Combined DNA Vaccination, Host Conditioning, and Adoptive Transfer
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Inhibition of STAT3 Promotes the Efficacy of Adoptive Transfer Therapy Using Type-1 CTLs by Modulation of the Immunological Microenvironment in a Murine Intracranial Glioma
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Immunological responses in a patient with glioblastoma multiforme treated with sequential courses of temozolomide and immunotherapy: Case study
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C. A. Marques, P. S. Hahnel, C. Wolfel, S. Thaler, C. Huber, M. Theobald, and M. Schuler
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A. Barber, T. Zhang, and C. L. Sentman
Immunotherapy with Chimeric NKG2D Receptors Leads to Long-Term Tumor-Free Survival and Development of Host Antitumor Immunity in Murine Ovarian Cancer
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A. Jorritsma, R. Gomez-Eerland, M. Dokter, W. van de Kasteele, Y. M. Zoet, I. I. N. Doxiadis, N. Rufer, P. Romero, R. A. Morgan, T. N. M. Schumacher, et al.
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K. H. Yi, H. Nechushtan, W. J. Bowers, G. R. Walker, Y. Zhang, D. G. Pham, E. R. Podack, H. J. Federoff, K. A. Tolba, and J. D. Rosenblatt
Adoptively Transferred Tumor-Specific T Cells Stimulated Ex vivo Using Herpes Simplex Virus Amplicons Encoding 4-1BBL Persist in the Host and Show Antitumor Activity In vivo
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J. N. Kochenderfer and R. E. Gress
A Comparison and Critical Analysis of Preclinical Anticancer Vaccination Strategies
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C. M. Paulos, A. Kaiser, C. Wrzesinski, C. S. Hinrichs, L. Cassard, A. Boni, P. Muranski, L. Sanchez-Perez, D. C. Palmer, Z. Yu, et al.
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D. F. McDermott and M. B. Atkins
More Support for the Judicious Use of High-Dose Interleukin-2 in Patients With Advanced Melanoma
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M. Matter, V. Pavelic, D. D. Pinschewer, S. Mumprecht, B. Eschli, T. Giroglou, D. von Laer, and A. F. Ochsenbein
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J. Schlom, P. M. Arlen, and J. L. Gulley
Cancer Vaccines: Moving Beyond Current Paradigms
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J. M. Curtsinger, M. Y. Gerner, D. C. Lins, and M. F. Mescher
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L.-X. Wang, S. Shu, M. L. Disis, and G. E. Plautz
Adoptive transfer of tumor-primed, in vitro activated, CD4+ T effector cells (TEs) combined with CD8+ TEs provides intratumoral TE proliferation and synergistic antitumor response
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Y. Zhao, M. R. Parkhurst, Z. Zheng, C. J. Cohen, J. P. Riley, L. Gattinoni, N. P. Restifo, S. A. Rosenberg, and R. A. Morgan
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Y. Dang, K. L. Knutson, V. Goodell, C. dela Rosa, L. G. Salazar, D. Higgins, J. Childs, and M. L. Disis
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M. N. Lopez, C. Pereda, M. Ramirez, A. Mendoza-Naranjo, A. Serrano, A. Ferreira, R. Poblete, A. M. Kalergis, R. Kiessling, and F. Salazar-Onfray
Melanocortin 1 Receptor Is Expressed by Uveal Malignant Melanoma and Can Be Considered a New Target for Diagnosis and Immunotherapy
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L. Bracci, F. Moschella, P. Sestili, V. La Sorsa, M. Valentini, I. Canini, S. Baccarini, S. Maccari, C. Ramoni, F. Belardelli, et al.
Cyclophosphamide Enhances the Antitumor Efficacy of Adoptively Transferred Immune Cells through the Induction of Cytokine Expression, B-Cell and T-Cell Homeostatic Proliferation, and Specific Tumor Infiltration
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S. R. Riddell
Engineering Antitumor Immunity by T-Cell Adoptive Immunotherapy
Hematology, January 1, 2007; 2007(1): 250 - 256.
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T. C. Wehler, M. Nonn, B. Brandt, C. M. Britten, M. Grone, M. Todorova, I. Link, S. A. Khan, R. G. Meyer, C. Huber, et al.
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J. C. Yang and R. Childs
Immunotherapy for Renal Cell Cancer
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S. Kausche, T. Wehler, E. Schnurer, V. Lennerz, W. Brenner, S. Melchior, M. Grone, M. Nonn, S. Strand, R. Meyer, et al.
Superior Antitumor In vitro Responses of Allogeneic Matched Sibling Compared with Autologous Patient CD8+ T Cells
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D. Montagna, R. Maccario, F. Locatelli, E. Montini, S. Pagani, F. Bonetti, L. Daudt, I. Turin, D. Lisini, C. Garavaglia, et al.
Emergence of antitumor cytolytic T cells is associated with maintenance of hematologic remission in children with acute myeloid leukemia
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A. Mackensen, N. Meidenbauer, S. Vogl, M. Laumer, J. Berger, and R. Andreesen
Phase I Study of Adoptive T-Cell Therapy Using Antigen-Specific CD8+ T Cells for the Treatment of Patients With Metastatic Melanoma
J. Clin. Oncol., November 1, 2006; 24(31): 5060 - 5069.
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