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

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...

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Published inJournal of clinical oncology Vol. 19; no. 6; pp. 1848 - 1854
Main Authors SIMON, Richard M, STEINBERG, Seth M, HAMILTON, Michael, HILDESHEIM, Allan, KHLEIF, Samir, KWAK, Larry W, MACKALL, Crystal L, SCHLOM, Jeffrey, TOPALIAN, Suzanne L, BERZOFSKY, Jay A
Format Journal Article
LanguageEnglish
Published Baltimore, MD American Society of Clinical Oncology 15.03.2001
Lippincott Williams & Wilkins
Subjects
Adjuvants, Immunologic - therapeutic use
Antineoplastic agents
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Cancer Vaccines - therapeutic use
Cohort Studies
Endpoint Determination
Humans
Immunocompromised Host
Immunotherapy
Medical sciences
Neoplasms - drug therapy
Neoplasms - virology
Pharmacology. Drug treatments
Randomized Controlled Trials as Topic
Research Design
Treatment Outcome
Antineoplastic agent
Human
Randomization
Treatment
Immunotherapy
Clinical trial
Vaccine
Review
Malignant tumor
Comparative study
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Summary: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.
ISSN:0732-183X
1527-7755
DOI:10.1200/jco.2001.19.6.1848