Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design.

ABSTRACT:

Purpose

Phase I clinical trials are generally conducted to identify the maximum tolerated dose (MTD) or the biologically active dose (BAD) using a traditional dose-escalation design. This design may not be applied to cancer vaccines, given their unique mechanism of action. The FDA recently published "Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines." However, many questions about the design of cancer vaccine studies remain unanswered.

Experimental design

We analyzed the toxicity profile in 239 phase I therapeutic cancer vaccine trials. We addressed the ability of dose escalation to determine the MTD or the BAD in trials that used a dose-escalation design.

Results

The rate of grade 3/4 vaccine-related systemic toxicities was 1.25 adverse e

SUBMITTER: Rahma OE 

PROVIDER: S-EPMC4167476 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature