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

• Published in: Journal 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
• Language: English
• 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

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...