Caroline C. Sigman

CCS Associates (United States)

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Gary J. Kelloff

National Cancer Institute

James A. Crowell

Indiana University Bloomington

Vernon E. Steele

National Cancer Institute

Ernest T. Hawk

The University of Texas MD Anderson Cancer Center

Charles W. Boone

Center for Health Care Services

Ronald A. Lubet

National Cancer Institute

Howard R. Higley

CCS Associates (United States)

Lata Mukundan

Amgen (United States)

Ilan R. Kirsch

Adaptive Biotechnologies (United States)

J. Milburn Jessup

Institute for Bioscience and Biotechnology Research

Cooperative Institutions

National Cancer Institute

119

National Institutes of Health

The University of Texas MD Anderson Cancer Center

Memorial Sloan Kettering Cancer Center

Harvard University

Johns Hopkins University

Dana-Farber Cancer Institute

Center for Cancer Research

SRI International

University of California, San Francisco

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

Journal of Cellular Biochemistry (1996)

Gary J. Kelloff James A. Crowell Ernest T. Hawk Vernon E. Steele Ronald A. Lubet

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.

Drug Development

Celecoxib

10.1002/jcb.240630705

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Citations (192)

Development of Breast Cancer Chemopreventive Drugs

The Breast Journal (1995)

Gary J. Kelloff Charles W. Boone James A. Crowell Susan Nayfield Ernest T. Hawk

Abstract: Chemoprevention, or intervention with chemical agents at the precancer stage to avoid or slow the development of the carcinogenic process, is one strategy to reduce both the incidence of breast cancer and its mortality. Systematic development of cancer chemopreventive drugs calls for evaluation of pre-clinical efficacy in well-characterized in vitro screens and animal cancer models. Highly promising agents are also included in traditional pre-clinical toxicity tests performed in two species. The most promising and least toxic agents enter clinical trials, including both phase I safety and pharmacokinetics evaluations and phase II and III efficacy studies. The use of populations with defined, measurable biologic alterations in tissue occurring prior to cancer development, i.e. intermediate biomarkers, is important to successful phase II chemoprevention trials. The intermediate biomarkers may be of several types, such as histological/premalignant lesions, proliferative, genetic/regulatory, differentiation-related, or biochemical. For example, ductal and lobular carcinoma in situ are premalignant lesions in the human breast. These lesions are tissue at very high risk of malignant progression and also have the potential to be modulated by chemopreventive agents. In addition, other types of biomarkers may be identified within the lesions. These biomarkers could then serve as surrogate trial end-points, instead of cancer incidence, for use in shorter, less costly trials.

Lobular carcinoma

10.1111/j.1524-4741.1995.tb00250.x

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Citations (6)

Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic

Cancer Prevention Research (2011)

Frank L. Meyskens Gregory A. Curt Dean E. Brenner Gary Gordon Ronald B. Herberman

Abstract This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs. Cancer Prev Res; 4(3); 311–23. ©2011 AACR.

Cancer drugs

Regulatory Science

Cancer Prevention

10.1158/1940-6207.capr-09-0014

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Citations (50)

Synthesis, chemical characterization, and mutagenic activities of promutagens produced by pyrolysis of proteinaceous substances

Environmental Mutagenesis (1981)

John H. Peters Kristien Mortelmans Elmer J. Reist Caroline C. Sigman Ronald J. Spanggord

Abstract Chemical and mutagenic characteristics of TRP‐P‐1, TRP‐P‐2, GLU‐P‐1, GLU‐P‐2, GLOB‐P‐1, and GLOB‐P‐2 were evaluated. We synthesized TRP‐P‐1 and TRP‐P‐2 and also obtained samples of these compounds from a commercial source. By GC‐MS analysis, the samples of TRP‐P‐2, GLUs, and GLOBs were more than 99% pure; but the samples of TRP‐P‐1 contained 11–17% of different impurities. These impurities had no effect on the mutagenicity of these chemicals in the Ames test using either strain TA98 or TA100 of Salmonella typhimurium. All six compounds were inactive without metabolic activation and the γ‐carbolines (TRPs) were more active in both strains than the α‐carbolines (GLOBs). GLU‐P‐1 was the most active of the promutagens tested in both TA98 (41,000 revertants/μg) and TA100 (6,580 revertants (μg). In TA98 the order of activity was GLU‐P‐1 > TRP‐P‐2 > TRP‐P‐1 > GLU‐P‐2 ≅ GLOB‐P‐2 > GLOB‐P‐1. In TA100 the order of activity was GLU‐P‐1 ≫ GLU‐P‐2 > TRP‐P‐2 ≅ TRP‐P‐1 ≫ GLOB‐P‐1 ≅ GLOB‐P‐2. We determined the UV absorption and fluorescence characteristics of these compounds, and of HM and NHM, and established an HPLC procedure for their resolution. Sensitivities in the picogram range were attainable using fluorescence detection.

10.1002/em.2860030606

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Citations (10)

Supplementary Table S1: IMWG Criteria for MRD negativity from The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications

Kenneth C. Anderson Daniel Auclair Gary J. Kelloff Caroline C. Sigman Hervé Avet‐Loiseau

<p>Adapted from: Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol 2016;17:e328-46.</p>

Minimal Residual Disease

Negativity effect

Value (mathematics)

10.1158/1078-0432.22468983

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Citations (0)

Supplementary Appendices from Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic

Frank L. Meyskens Gregory A. Curt Dean E. Brenner Gary Gordon Ronald B. Herberman

Supplementary Appendices from Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic

Drug approval

Cancer drugs

10.1158/1940-6207.22525025

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Citations (0)

Cancer and the Cyclo-oxygenase Enzyme

American Journal of Cancer (2003)

Ernest T. Hawk Jaye L. Viner Asad Umar William F. Anderson Caroline C. Sigman

Celecoxib

Cancer Prevention

COX-2 inhibitor

Chemoprotective

10.2165/00024669-200302010-00003

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Citations (15)

A study of anthraquinone dyes for the selection of candidates for carcinogen bioassay

Journal of Environmental Science and Health Part A Environmental Science and Engineering (1985)

Caroline C. Sigman P. Papa M. K. Doeltz L. R. Perry A. M. Twhigg

Abstract A study of anthraquinone dyes as candidates for nomination to the National Cancer Institute (NCI) Chemical Selection Working Group (CSWG) for carcinogenesis bioassay is described. The preliminary candidate list of dyes was provided by the U.S. Operating Committee (USOC) of the Ecological and Toxicological Association of the Dyestuffs Manufacturing Industry (ETAD). After the identification and elimination of the chemicals considered previously by the CSWG, already tested adequately, or on test currently, information on the remaining candidates was evaluated according to such factors as chemical structure, potential exposure, and suspicion of carcinogenicity. On the basis of these considerations, 16 chemicals were judged to be the best candidates for testing. Twelve chemicals were nominated for carcinogenesis bloassay; four for inclusion in the National Toxicology Program (NTP) Short Term Testing Program.

Nomination

Anthraquinones

10.1080/10934528509375234

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Citations (9)

Evaluation and classification of the potential carcinogenicity of organic air pollutants

Journal of Environmental Science and Health Part A Environmental Science and Engineering (1982)

C. Tucker Helmes Dwight Atkinson James Jaffer Caroline C. Sigman K. L. Thompson

Abstract Data on the carcinogenicity and Ames Salmonella test muta‐genicity were compiled for 671 organic chemicals reported to be potential air pollutants. Development of the data base entailed an evaluation of published reports of carcinogenicity and mutagenicity test results available in the open literature. Criteria were established for classifying the chemicals as recognized carcinogens, suspected carcinogens, tumor promoters or cocarcinogens, and mutagens or suspected mutagens. Confirmation of chemicals as ambient air pollutants was attempted only for the chemicals classified into a category of potential carcinogenicity other than unknown. Primary and secondary literature sources were searched for the reported detection of the chemicals as ambient air pollutants. This work resulted in the classification of 77 air pollutants as potential human carcinogens, as demonstrated by the categorization of 25 air pollutants as recognized carcinogens, 20 air pollutants as suspected carcinogens, 15 air pollutants as tumor promoters/cocarcinogens, and 50 air pollutants as mutagens or suspected mutagens. For 17 of the 50 air pollutants classified as mutagens or suspected mutagens, no adequate positive carcino‐genicity data were found. No evidence of mutagenicity determined by the Ames test was found for seven of the 25 recognized carcinogens or for nine of the 20 suspected carcinogens. Notes This study was supported by the National Cancer Institute, Contract No. NO1‐CP‐95607 Reprints may be obtained from C. T. Helmes and also from Dr. H. F. Kraybill, Scientific Coordinator for the Office of Environmental Cancer, Division of Cancer Cause and Prevention, National Cancer Institute, Landow Building, Room C337, 7910 Woodmont Avenue, Bethesda, Maryland 20205

Ames test

10.1080/10934528209375038

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Citations (33)

Progress in clinical chemoprevention.

PubMed (1997)

Gary J. Kelloff Ernest T. Hawk Judith E. Karp James A. Crowell C W Boone

Drug Development

Cancer Prevention

Source

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Citations (76)