| A phase I study of nonmyeloablative chemotherapy and adoptive transfer of autologous tumor antigen-specific T lymphocytes in patients with metastatic melanoma. | |
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MedLine Citation:
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PMID: 12000866 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This report describes a phase I clinical trial using nonmyeloablative, lympho-depleting chemotherapy in combination with adoptive immunotherapy in patients with metastatic melanoma. The chemotherapy-conditioning schedule that induced transient lymphopenia consisted of cyclophosphamide (30 or 60 mg/kg per day for 2 days) followed by fludarabine (25 mg/m(2) per day for 5 days). Immunotherapy for all patients consisted of in vitro expanded, tumor-reactive, autologous T-cell clones selected for high avidity recognition of melanoma antigens. Cohorts of three to six patients each received either no interleukin (IL)-2, low-dose IL-2 (72,000 IU/kg intravenously three times a day to a maximum of 15 doses), or high-dose IL-2 (720,000 IU/kg intravenously three times a day for a maximum of 12 doses). The toxicities associated with this treatment were transient and included neutropenia and thrombocytopenia that resolved in all patients. High dose intravenous IL-2 was better tolerated by patients after chemotherapy than during previous immunotherapy cycles without chemotherapy. No patient exhibited an objective clinical response to treatment, although five patients demonstrated mixed responses or transient shrinkage of metastatic deposits. This study established a nonmyeloablative-conditioning regimen that could be safely administered in conjunction with adoptive T-cell transfer and IL-2 in patients with metastatic melanoma. |
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Authors:
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Mark E Dudley; John R Wunderlich; James C Yang; Patrick Hwu; Douglas J Schwartzentruber; Suzanne L Topalian; Richard M Sherry; Francesco M Marincola; Susan F Leitman; Claudia A Seipp; Linda Rogers-Freezer; Kathleen E Morton; Azam Nahvi; Sharon A Mavroukakis; Donald E White; Steven A Rosenberg |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Journal of immunotherapy (Hagerstown, Md. : 1997) Volume: 25 ISSN: 1524-9557 ISO Abbreviation: J. Immunother. Publication Date: 2002 May-Jun |
Date Detail:
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Created Date: 2002-05-09 Completed Date: 2002-10-03 Revised Date: 2009-11-18 |
Medline Journal Info:
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Nlm Unique ID: 9706083 Medline TA: J Immunother Country: United States |
Other Details:
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Languages: eng Pagination: 243-51 Citation Subset: IM |
Affiliation:
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Surgery Branch, National Cancer Institute, Building 10, Room 2B08, 9000 Rockville Pike, Bethesda, MD 20892, USA. Mark_Dudley@nih.gov |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Antigens, Neoplasm / immunology* Female Humans Immunotherapy, Adoptive* Interleukin-2 / therapeutic use Male Melanoma / secondary*, therapy* Middle Aged T-Lymphocytes / immunology* |
| Grant Support | |
ID/Acronym/Agency:
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Z01 SC003811-33/SC/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antigens, Neoplasm; 0/Interleukin-2 |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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