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Cancer Therapy: Clinical

Clinical Responses in a Phase II Study Using Adoptive Transfer of Short-term Cultured Tumor Infiltration Lymphocytes in Metastatic Melanoma Patients

Michal J. Besser, Ronnie Shapira-Frommer, Avraham J. Treves, Dov Zippel, Orit Itzhaki, Liat Hershkovitz, Daphna Levy, Adva Kubi, Einat Hovav, Natalia Chermoshniuk, Bruria Shalmon, Izhar Hardan, Raphael Catane, Gal Markel, Sara Apter, Alon Ben-Nun, Iryna Kuchuk, Avichai Shimoni, Arnon Nagler and Jacob Schachter
Michal J. Besser
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Ronnie Shapira-Frommer
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Avraham J. Treves
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Dov Zippel
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Orit Itzhaki
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Liat Hershkovitz
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Daphna Levy
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Adva Kubi
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Einat Hovav
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Natalia Chermoshniuk
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Bruria Shalmon
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Izhar Hardan
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Raphael Catane
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Gal Markel
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Sara Apter
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Alon Ben-Nun
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Iryna Kuchuk
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Avichai Shimoni
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Arnon Nagler
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Jacob Schachter
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DOI: 10.1158/1078-0432.CCR-10-0041 Published May 2010
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Abstract

Purpose: Adoptive cell therapy with autologous tumor-infiltrating lymphocytes (TIL) has shown promising results in metastatic melanoma patients. Although objective response rates of over 50% have been reported, disadvantages of this approach are the labor-intensive TIL production and a very high drop-out rate of enrolled patients, limiting its widespread applicability.

Previous studies showed a clear correlation between short TIL culture periods and clinical response. Therefore, we used a new TIL production technique using unselected, minimally cultured, bulk TIL (Young-TIL). The use of Young-TIL is not restricted to human leukocyte antigen (HLA)-A2 patients.

The purpose of this study is to explore the efficacy and toxicity of adoptively transferred Young-TIL following lympho-depleting chemotherapy in metastatic melanoma patients, refractory to interleukin-2 and chemotherapy.

Experimental Design: Young-TIL cultures for 90% of the patients were successfully generated, enabling the treatment of most enrolled patients. We report here the results of 20 evaluated patients.

Results: Fifty percent of the patients achieved an objective clinical response according to the Response Evaluation Criteria in Solid Tumors, including two ongoing complete remissions (20+, 4+ months) and eight partial responses (progression-free survival: 18+, 13+, 10+, 9, 6+, 4, 3+, and 3 months). All responders are currently alive. Four additional patients showed disease stabilization. Side effects were transient and manageable.

Conclusion: We showed that lympho-depleting chemotherapy followed by transfer of short-term cultured TIL can mediate tumor regression in 50% of metastatic melanoma with manageable toxicity. The convincing clinical results combined with the simplification of the process may thus have a major effect on cell therapy of cancer. Clin Cancer Res; 16(9); 2646–55. ©2010 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received January 10, 2010.
  • Revision received February 25, 2010.
  • Accepted February 26, 2010.
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Clinical Cancer Research: 16 (9)
May 2010
Volume 16, Issue 9
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Clinical Responses in a Phase II Study Using Adoptive Transfer of Short-term Cultured Tumor Infiltration Lymphocytes in Metastatic Melanoma Patients
Michal J. Besser, Ronnie Shapira-Frommer, Avraham J. Treves, Dov Zippel, Orit Itzhaki, Liat Hershkovitz, Daphna Levy, Adva Kubi, Einat Hovav, Natalia Chermoshniuk, Bruria Shalmon, Izhar Hardan, Raphael Catane, Gal Markel, Sara Apter, Alon Ben-Nun, Iryna Kuchuk, Avichai Shimoni, Arnon Nagler and Jacob Schachter
Clin Cancer Res May 1 2010 (16) (9) 2646-2655; DOI: 10.1158/1078-0432.CCR-10-0041

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Clinical Responses in a Phase II Study Using Adoptive Transfer of Short-term Cultured Tumor Infiltration Lymphocytes in Metastatic Melanoma Patients
Michal J. Besser, Ronnie Shapira-Frommer, Avraham J. Treves, Dov Zippel, Orit Itzhaki, Liat Hershkovitz, Daphna Levy, Adva Kubi, Einat Hovav, Natalia Chermoshniuk, Bruria Shalmon, Izhar Hardan, Raphael Catane, Gal Markel, Sara Apter, Alon Ben-Nun, Iryna Kuchuk, Avichai Shimoni, Arnon Nagler and Jacob Schachter
Clin Cancer Res May 1 2010 (16) (9) 2646-2655; DOI: 10.1158/1078-0432.CCR-10-0041
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