Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer All patients provided informed consent.
dc.contributor.author | Higano, Celestia S. | en_US |
dc.contributor.author | Corman, John M. | en_US |
dc.contributor.author | Smith, David C. | en_US |
dc.contributor.author | Centeno, Arthur S. | en_US |
dc.contributor.author | Steidle, Christopher P. | en_US |
dc.contributor.author | Gittleman, Marc | en_US |
dc.contributor.author | Simons, Jonathan W. | en_US |
dc.contributor.author | Sacks, Natalie | en_US |
dc.contributor.author | Aimi, Junko | en_US |
dc.contributor.author | Small, Eric J. | en_US |
dc.date.accessioned | 2008-10-01T15:23:35Z | |
dc.date.available | 2009-10-02T17:27:37Z | en_US |
dc.date.issued | 2008-09-01 | en_US |
dc.identifier.citation | Higano, Celestia S.; Corman, John M.; Smith, David C.; Centeno, Arthur S.; Steidle, Christopher P.; Gittleman, Marc; Simons, Jonathan W.; Sacks, Natalie; Aimi, Junko; Small, Eric J. (2008). "Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer All patients provided informed consent. ." Cancer 113(5): 975-984. <http://hdl.handle.net/2027.42/60980> | en_US |
dc.identifier.issn | 0008-543X | en_US |
dc.identifier.issn | 1097-0142 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/60980 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=18646045&dopt=citation | en_US |
dc.description.abstract | BACKGROUND This open-label, multicenter, dose-escalation study evaluated multiple dose levels of immunotherapy in patients with metastatic hormone-refractory prostate cancer (HRPC). The immunotherapy, based on the GVAX platform, consisted of 2 allogeneic prostate-carcinoma cell lines modified to secrete granulocyte-macrophage-colony-stimulating factor (GM-CSF). METHODS Dose levels ranged from 100 × 10 6 cells q28d × 6 to 500 × 10 6 cells prime/300 × 10 6 cells boost q14d × 11. Endpoints included safety, immunogenicity, overall survival, radiologic response, prostate-specific antigen (PSA) kinetics, and serum GM-CSF pharmacokinetics. RESULTS Eighty men, median age 69 years (range, 49-90 years), were treated. The most common adverse effect was injection-site erythema. Overall, the immunotherapy was well tolerated. A maximal tolerated dose was not established. The median survival time was 35.0 months in the high-dose group, 20.0 months in the mid-dose, group, and 23.1 months in the low-dose group. PSA stabilization occurred in 15 (19%) patients, and a >50% decline in PSA was seen in 1 patient. The proportion of patients who generated an antibody response to 1 or both cell lines increased with dose and included 10 of 23 (43%) in the low-dose group, 13 of 18 (72%) in the mid-dose group, and 16 of 18 (89%) in the high-dose group ( P = .002; Cochran-Armitage trend test). CONCLUSIONS This immunotherapy was well tolerated. Immunogenicity and overall survival varied by dose. Two phase 3 trials in patients with metastatic HRPC are underway. Cancer 2008. © 2008 American Cancer Society. | en_US |
dc.format.extent | 193021 bytes | |
dc.format.extent | 3118 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Life and Medical Sciences | en_US |
dc.subject.other | Cancer Research, Oncology and Pathology | en_US |
dc.title | Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer All patients provided informed consent. | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Oncology and Hematology | en_US |
dc.subject.hlbsecondlevel | Public Health | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Departments of Internal Medicine and Urology, University of Michigan Medical Center, Ann Arbor, Michigan | en_US |
dc.contributor.affiliationother | Departments of Oncology and Urology, University of Washington, Seattle, Seattle, Washington ; Fax: (650) 595-0180 ; Seattle Cancer Care Alliance, 825 Eastlake Ave. E, P.O. Box 19023, Seattle, WA 98109-1023 | en_US |
dc.contributor.affiliationother | Floyd and Delores Jones Cancer Center, Virginia Mason Medical Center, Seattle, Washington | en_US |
dc.contributor.affiliationother | Urology San Antonio, San Antonio, Texas | en_US |
dc.contributor.affiliationother | Northeast Indiana Research, Fort Wayne, Indiana | en_US |
dc.contributor.affiliationother | South Florida Medical Research, Aventura, Florida | en_US |
dc.contributor.affiliationother | Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia ; J.W. Simons is a coinventor of 2 issued US patents (US Pat. Nos. 7,226,606 and 7,217,421), has pending applications that are exclusively licensed to and co-owned by Cell Genesys, and has received honoraria from Cell Genesys for speaking engagements. | en_US |
dc.contributor.affiliationother | Department of Clinical Research, Cell Genesys, Inc, South San Francisco, California ; N. Sacks and J. Aimi are employees of Cell Genesys. | en_US |
dc.contributor.affiliationother | Department of Clinical Research, Cell Genesys, Inc, South San Francisco, California | en_US |
dc.contributor.affiliationother | Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California | en_US |
dc.identifier.pmid | 18646045 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/60980/1/23669_ftp.pdf | |
dc.identifier.doi | http://dx.doi.org/10.1002/cncr.23669 | en_US |
dc.identifier.source | Cancer | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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