© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 9, 646-651,
May 7, 2003
© 2003 Oxford University Press
COMMENTARY |
Development of Investigational Radiation Modifiers
For the Radiation Modifier Working Group of the National Cancer Institute
Affiliations of authors: A. D. Colevas, J. Mitchell, K. Camphausen, C. N. Coleman, National Cancer Institute, Bethesda, MD; J. M. Brown, Stanford University, Stanford, CA; S. Hahn, University of Pennsylvania, Philadelphia, PA.
Correspondence to: A. Dimitrios Colevas, M.D., Investigational Drug Branch, NCI/CTEP, 6130 Executive Blvd., EPN 7124, Rockville, MD 20892–7426 (e-mail: colevasd@ctep.nci.nih.gov).
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Historically, clinically useful modifiers of radiation therapy have been conventional chemotherapeutic agents (e.g., 5-fluorouracil and thymidylate synthase inhibitors, cisplatin and related compounds, and taxanes) (1–4) administered on a schedule designed to optimize the interaction between the agent and radiation. The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment and Diagnosis, National Cancer Institute, sponsored a meeting of the Radiation Modifier Working Group June 24–26, 2002, in Rosslyn, VA. The charge of the working group was to review and evaluate past and current preclinical and clinical approaches to the development of combination drug and radiation anticancer therapies and to provide practical guidelines for selecting evaluation criteria for radiation modifiers.
Additional potentially useful molecular targets for agents that modify the effects of radiation are emerging as our knowledge of the human genome and proteome continues to expand. Obstacles to
PRECLINICAL STUDIES OF RADIATION MODIFIERS
Types of Preclinical Data Needed
Appropriate Assays
In Vitro Assays
In Vivo Assays
Appropriate Solid Tumor Models
Demonstration of Radiosensitization of Tumors or Tumor Cells
Demonstration of Lack of Sensitization in Normal Cells or Tissues
Need for Clinically Relevant Exposures
PHASE I STUDIES OF RADIATION MODIFIERS
Prerequisites of Phase I Trials
Single-agent radiation modifier pharmacokinetic data. Single-agent pharmacodynamic data. Single-agent safety data. Evaluation of therapeutic index. Phase I Design and Implementation
PHASE II TRIALS AND BEYOND: DESIGN AND IMPLEMENTATION
SUMMARY
APPENDIX
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