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Chemoprevention clinical trials
G J Kelloff1, C W Boone, W F Malone
1Chemoprevention Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
Mutation Research
|June 1, 1992
Summary
The National Cancer Institute is advancing cancer prevention drugs through clinical trials. Key drug classes include retinoids, beta-carotene, and calcium compounds, with new agents in development.
Area of Science:
- Oncology
- Pharmacology
- Preventive Medicine
Background:
- The National Cancer Institute's Chemoprevention Branch is dedicated to developing pharmaceutical interventions for cancer delay or prevention in humans.
- Clinical trials are crucial for evaluating the efficacy and safety of potential cancer chemopreventive agents.
Purpose of the Study:
- To summarize the progress and key agents being investigated in the National Cancer Institute's cancer chemoprevention clinical trials program.
- To highlight advanced agent classes and promising new compounds under evaluation for cancer prevention.
Main Methods:
- Sponsorship and oversight of 12 Phase I and 22 Phase II and III clinical trials focused on cancer chemoprevention.
- Categorization of advanced agent classes: retinoids, beta-carotene, and calcium compounds.
- Identification of six promising new compounds in early-stage (Phase I/II) clinical trials.
Main Results:
- Retinoids (including 13-cis-retinoic acid, retinol, 4-hydroxyphenylretinamide) are involved in nine studies.
- Beta-carotene is being investigated in seven studies.
- Calcium compounds are part of three studies, with six novel compounds (piroxicam, ibuprofen, oltipraz, difluoromethylornithine, glycyrrhetinic acid, N-acetylcysteine) in earlier trials.
Conclusions:
- Significant progress is being made in the development of cancer chemopreventive agents through a robust clinical trial program.
- Key considerations for chemopreventive agent development include long-term administration, oral route feasibility, and balancing toxicity with cancer risk.