A clinical development paradigm for cancer vaccines and related biologics

Journal of Immunotherapy

Volumn 30, Issue 1, 2007, Pages 1-15

  Hoos, Axel ^a   Parmiani, Giorgio ^b   Hege, Kristen ^c   Sznol, Mario ^d   Loibner, Hans ^e   Eggermont, Alexander ^f   Urba, Walter ^g   Blumenstein, Brent ^h   Sacks, Natalie ^c   Keilholz, Ulrich ⁱ   Nichol, Geoffrey ^j  

^a BRISTOL MYERS SQUIBB   (United States)

^b NATIONAL CANCER INSTITUTE   (Italy)

^c CELL GENESYS INC   (United States)

^d YALE UNIVERSITY   (United States)

^e HL Biosciences   (Austria)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g EARLE A CHILES RESEARCH INSTITUTE   (United States)

^h TriArc Consulting   (United States)

ⁱ FREIE UNIVERSITÄT BERLIN   (Germany)

^j MEDAREX INC   (United States)

more..

Author keywords

Cancer vaccines; Clinical development; Clinical trial; Paradigm; Trial design

Indexed keywords

BIOLOGICAL MARKER; CANCER VACCINE; CYTOTOXIC AGENT;

BIOASSAY; DRUG DOSE REGIMEN; DRUG EFFICACY; HUMAN; IMMUNE RESPONSE; IMMUNE SYSTEM; METHODOLOGY; OUTCOME ASSESSMENT; PATIENT SELECTION; PRIORITY JOURNAL; QUALITY OF LIFE; REGULATORY MECHANISM; REVIEW; RISK ASSESSMENT; STATISTICAL ANALYSIS; SURVIVAL; TOXICITY TESTING;

CANCER VACCINES; CLINICAL TRIALS; HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS;

EID: 33845993628     PISSN: 15249557     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.cji.0000211341.88835.ae     Document Type: Review

References (13)

1. Ribas A, Butterfield LH, Glaspy JA, et al. Current developments in cancer vaccines and cellular immunotherapy. J Clin Oncol. 2003;21:2415-2432.
2. Berinstein N. Overview of therapeutic vaccination approaches for cancer. Semin Oncol. 2003;30(suppl 8):1-8.
3. Therasse P, Arbuck S, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205-216.
4. Keilholz U, Weber J, Finke JH, et al. Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy. J Immunother. 2002;25:97-138.
5. Hobeika AC, Morse MA, Osada T, et al. Enumerating antigen-specific T-cell responses in peripheral blood: a comparison of peptide MHC Tetramer, ELISpot, and intracellular cytokine analysis. J Immunother. 2005;28:63-72.
6. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep. 1985;69:1375-1381.
7. U.S. Food and Drug Administration. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics, April 2005.
8. U.S. Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims, February 2006.
9. Lotze MT, Wang E, Marincola FM, et al. Workshop on cancer biometrics: identifying biomarkers and surrogates of cancer in patients. J Immunother. 2005;28:79-119.
10. Wang E, Panelli MC, Monsurro V, et al. Gene expression profiling of anti-cancer immune responses. Curr Op Mol Ther. 2004;6:288-295.
11. Baker SG, Kramer SG. A perfect correlate does not a surrogate make. BMC Med Res Methodol. 2003;3:16.
12. Sondak VK, Sosman JA. Results of clinical trials with an allogenic melanoma tumor cell lysate vaccine: melacine. Semin Cancer Biol. 2003;13:409-415.
13. Hughes T, Branford S. Molecular monitoring of BCR-ABL as a guide to clinical management in chronic myeloid leukemia. Blood Rev. 2006;20:29-41.