Strategy and planning for chemopreventive drug development: Clinical development plans II

Authors

  • Gary J. Kelloff MD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • James A. Crowell PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Ernest T. Hawk MD, MPH,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Vernon E. Steele PhD, MPH,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Ronald A. Lubet PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Charles W. Boone MD, PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Joseph M. Covey PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Pharmacology Branch, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), NCI, Bethesda, MD 20892
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  • Linda A. Doody PhD,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    2. CCS Associates, Mountain View, CA 94043
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  • Gilbert S. Omenn MD, PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. University of Washington, Seattle, WA 98195
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  • Peter Greenwald MD, DrPH,

    1. Director, DCPC, NCI, Bethesda, MD 20892
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  • Waun K. Hong MD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. University of Texas, MD Anderson Cancer Center, Houston, TX 77030
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  • David R. Parkinson MD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Cancer Therapy Evaluation Program, DCTDC, NCI, Bethesda, MD 20892
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  • Donya Bagheri MS,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Gregory T. Baxter PhD,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Margaret Blunden MS,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Mary K. Doeltz,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Karen M. Eisenhauer PhD,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Karen Johnson MD, MPH,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Community Oncology and Rehabilitation Branch, DCPC, NCI, Bethesda, MD 20892
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  • Gene G. Knapp MS,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • David G. Longfellow PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Chemical and Physical Carcinogenesis Branch, Division of Cancer Biology, NCI, Bethesda, MD 20892
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  • Winfred F. Malone PhD, MPH,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Susan G. Nayfield MD, MSc,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Harold E. Seifried PhD,

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Chemical and Physical Carcinogenesis Branch, Division of Cancer Biology, NCI, Bethesda, MD 20892
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  • Leah M. Swall MS,

    1. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
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  • Caroline C. Sigman PhD

    1. Agent Development Committee, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892
    2. Agent Working Group, Chemoprevention Branch, DCPC, NCI, Bethesda, MD 20892
    3. CCS Associates, Mountain View, CA 94043
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Abstract

This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole-3-carbinol, perillyl alcohol, phenethyl isothiocyanate, 9-cis-retinoic acid, 13-cis-retinoic acid, l-selenomethionine and 1,4-phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)-vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs. © 1997 Wiley-Liss, Inc.

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