Overcoming the hurdles of randomised clinical trials of therapeutic cancer vaccines

2010 ◽  
Vol 46 (9) ◽  
pp. 1514-1519 ◽  
Author(s):  
Tetsuro Sasada ◽  
Nobukazu Komatsu ◽  
Shigetaka Suekane ◽  
Akira Yamada ◽  
Masanori Noguchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Vaccines ◽  
Randomised Clinical Trials ◽  
Therapeutic Cancer Vaccines

scholarly journals From clinical trials to clinical practice: therapeutic cancer vaccines for the treatment of prostate cancer

2011 ◽  
Vol 10 (6) ◽  
pp. 743-753 ◽  
Author(s):  
Ravi A Madan ◽  
Jeanny B Aragon-Ching ◽  
James L Gulley ◽  
William L Dahut
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Cancer Vaccines ◽  
Therapeutic Cancer Vaccines

Clinical Trial Designs for the Early Clinical Development of Therapeutic Cancer Vaccines

2001 ◽  
Vol 19 (6) ◽  
pp. 1848-1854 ◽  
Author(s):  
Richard M. Simon ◽  
Seth M. Steinberg ◽  
Michael Hamilton ◽  
Allan Hildesheim ◽  
Samir Khleif ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Vaccines ◽  
Chemotherapeutic Agents ◽  
Clinical Development ◽  
Dose Finding ◽  
Tumor Vaccines ◽  
Wide Range ◽  
Clinical Trial Designs ◽  
Therapeutic Cancer Vaccines

ABSTRACT: There are major differences between therapeutic tumor vaccines and chemotherapeutic agents that have important implications for the design of early clinical trials. Many vaccines are inherently safe and do not require phase I dose finding trials. Patients with advanced cancers and compromised immune systems are not good candidates for assessing either the toxicity or efficacy of therapeutic cancer vaccines. The rapid pace of development of new vaccine candidates and the variety of possible adjuvants and modifications in method of administration makes it important to use efficient designs for clinical screening and evaluation of vaccine regimens. We review the potential advantages of a wide range of clinical trial designs for the development of tumor vaccines. We address the role of immunological endpoints in early clinical trials of tumor vaccines, investigate the design implications of attempting to use disease stabilization as an end point and discuss the difficulties of reliably utilizing historical control data. Several conclusions for expediting the clinical development of effective cancer vaccines are proposed.

scholarly journals Plasmacytoid Dendritic Cells and Cancer Immunotherapy

Cells ◽  
2022 ◽  
Vol 11 (2) ◽  
pp. 222
Author(s):  
Chunmei Fu ◽  
Li Zhou ◽  
Qing-Sheng Mi ◽  
Aimin Jiang
Keyword(s):  
Clinical Trials ◽  
T Cell ◽  
Cancer Immunotherapy ◽  
Cancer Vaccines ◽  
Critical Role ◽  
Dependent Manner ◽  
Cell Immunity ◽  
New Findings ◽  
Dc Vaccines ◽  
Therapeutic Cancer Vaccines

Despite largely disappointing clinical trials of dendritic cell (DC)-based vaccines, recent studies have shown that DC-mediated cross-priming plays a critical role in generating anti-tumor CD8 T cell immunity and regulating anti-tumor efficacy of immunotherapies. These new findings thus support further development and refinement of DC-based vaccines as mono-immunotherapy or combinational immunotherapies. One exciting development is recent clinical studies with naturally circulating DCs including plasmacytoid DCs (pDCs). pDC vaccines were particularly intriguing, as pDCs are generally presumed to play a negative role in regulating T cell responses in tumors. Similarly, DC-derived exosomes (DCexos) have been heralded as cell-free therapeutic cancer vaccines that are potentially superior to DC vaccines in overcoming tumor-mediated immunosuppression, although DCexo clinical trials have not led to expected clinical outcomes. Using a pDC-targeted vaccine model, we have recently reported that pDCs required type 1 conventional DCs (cDC1s) for optimal cross-priming by transferring antigens through pDC-derived exosomes (pDCexos), which also cross-prime CD8 T cells in a bystander cDC-dependent manner. Thus, pDCexos could combine the advantages of both cDC1s and pDCs as cancer vaccines to achieve better anti-tumor efficacy. In this review, we will focus on the pDC-based cancer vaccines and discuss potential clinical application of pDCexos in cancer immunotherapy.

scholarly journals Strategies for Cancer Vaccine Development

2010 ◽  
Vol 2010 ◽  
pp. 1-13 ◽  
Author(s):  
Matteo Vergati ◽  
Chiara Intrivici ◽  
Ngar-Yee Huen ◽  
Jeffrey Schlom ◽  
Kwong Y. Tsang
Keyword(s):  
Clinical Trials ◽  
Cancer Vaccine ◽  
Cancer Vaccines ◽  
T Regulatory Cells ◽  
Vaccine Development ◽  
Tumor Escape ◽  
Immunological Mechanisms ◽  
Clinical Benefits ◽  
Recent Phase ◽  
Therapeutic Cancer Vaccines

Treating cancer with vaccines has been a challenging field of investigation since the 1950s. Over the years, the lack of effective active immunotherapies has led to the development of numerous novel strategies. However, the use of therapeutic cancer vaccines may be on the verge of becoming an effective modality. Recent phase II/III clinical trials have achieved hopeful results in terms of overall survival. Yet despite these encouraging successes, in general, very little is known about the basic immunological mechanisms involved in vaccine immunotherapy. Gaining a better understanding of the mechanisms that govern the specific immune responses (i.e., cytotoxic T lymphocytes, CD4 T helper cells, T regulatory cells, cells of innate immunity, tumor escape mechanisms) elicited by each of the various vaccine platforms should be a concern of cancer vaccine clinical trials, along with clinical benefits. This review focuses on current strategies employed by recent clinical trials of therapeutic cancer vaccines and analyzes them both clinically and immunologically.

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