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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.
Abstract:
As part of a program to develop drugs which will delay or prevent cancer in humans, the Chemoprevention Branch, National Cancer Institute, National Institutes of Health, is sponsoring 12 Phase I and 22 Phase II and III clinical trials. Three agent classes are significantly advanced in the trials. These are the retinoids, including 13-cis-retinoic acid, retinol, and 4-hydroxyphenylretinamide (nine studies), beta-carotene (seven studies), and calcium compounds (three studies). In addition, six promising new compounds are in Phase I or Phase II trials. These are: piroxicam, ibuprofen, oltipraz (a dithiolthione), difluoromethylornithine, glycyrrhetinic acid, and N-acetylcysteine. Key concepts related to the development of cancer chemopreventive agents are (1) the need for long-term administration, (2) the need for oral route of administration, (3) the matching of toxic side effects to degree of cancer risk.
Insights
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.