期刊
JOURNAL OF CLINICAL ONCOLOGY
卷 27, 期 25, 页码 4047-4054出版社
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2008.19.9968
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资金
- National Institutes of Health (NIH) [K23 RR16489]
- NIH National Gene Vector Laboratory Program
- NIH National Center for Research Resources Clinical and Translational Science Award program [1UL1RR025011]
- US Army Medical Research and Materiel Command Prostate Cancer Research Program [W81XWH-05-1-0404]
Purpose Prostatic acid phosphatase (PAP) is a prostate tumor antigen. We have previously demonstrated that a DNA vaccine encoding PAP can elicit antigen-specific CD8+ T cells in rodents. We report here the results of a phase I/IIa trial conducted with a DNA vaccine encoding human PAP in patients with stage D0 prostate cancer. Patients and Methods Twenty-two patients were treated in a dose-escalation trial with 100 mu g, 500 mu g, or 1,500 mu g plasmid DNA, coadministered intradermally with 200 mu g granulocyte-macrophage colony-stimulating factor as a vaccine adjuvant, six times at 14-day intervals. All patients were observed for 1 year after treatment. Results No significant adverse events were observed. Three (14%) of 22 patients developed PAP-specific IFN gamma-secreting CD8+ T-cells immediately after the treatment course, as determined by enzyme-linked immunospot. Nine (41%) of 22 patients developed PAP-specific CD4+ and/or CD8+ T-cell proliferation. Antibody responses to PAP were not detected. Overall, the prostate-specific antigen (PSA) doubling time was observed to increase from a median 6.5 months pretreatment to 8.5 months on-treatment (P = .033), and 9.3 months in the 1-year post-treatment period (P = .054). Conclusion The demonstration that a DNA vaccine encoding PAP is safe, elicits an antigen-specific T-cell response, and may be associated with an increased PSA doubling time suggests that a multi-institutional phase II trial designed to evaluate clinical efficacy is warranted.
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