ATTACHMENT 3 The effect of Total Body Irradiation on Immunologic Tolerance of Bone Marrow and Homografts of Other Living Tissue Location: Baylor University College of Medicine Texas Medical Center Houston, Texas approximately 1953 - 1964. Researchers: Vincent P. Collins, M.D., Baylor University, Principal Investigator R. Kenneth Loeffler, M.D., Baylor University Organization: This research was conducted by the Baylor University College of Medicine. The work was initially supported under Armed Forces Special Weapons Project (AFSWP) contract DA-49-007-MD-428 and then supported by the Defense Atomic Support Agency (DASA) contract DA-49-146-XZ-032. Subjects: The subjects were patients at the Texas Medical Center. The majority had generalized neoplastic conditions. There were 112 patients treated in the study. Exposures ranged from 25r-250r in 1 day to 25r-545r over periods of time from 4 days to 3.5 years. Purpose: The goal of treatment by total body irradiations for patients disseminated cancer is relief of symptoms. Despite the fact that many patients were approaching the terminal stage when referred for treatment, therapeutic response was evident in may by decrease in size of nodes, relief of impending obstruction and by decreased narcotic requirements subsequent to relief of pain. In some instances, response was dramatic;; a few completely bedridden patients became ambulatory and several experienced long term remissions. Among the 112 patients there were more than 30 different types of cancer; since total body irradiation was given only for generalized disease, a survival of one year or even temporary remission was gratifying. Extensive data from clinical observations and laboratory tests were reported in series of reports to AFSWP and DASA throughout the period of the study. Value to DoD: In his summary report, Dr. Collins indicated a set of tables predicting the effect of total body irradiation based on clinical observations. He also included detailed and extensive tables of biochemical effects and hematological data. All of this can and probably was used to support predictive analysis of radiation effects on troops in a wartime environment. Records: Currently identified records are the reports submitted to AFSWP and DASA by the University of Baylor. The titles and dates of the reports indicate that certain reports are missing; the missing reports are being sought for review. Prepared by: CAPT C.B. GALLEY,AFRRI, ((310)-295-1048) POST-IRRADIATION SYNDROME IN MAN Location: Sloan Kettering Institute for Cancer Research (SKICR) 410 East 68th Street New York 21, New York 1 July 1954 to 31 January 1961 Researchers: James J. Nickson, MD - Sloan Kettering - Principal Investigator Henry J. Kock, MD - Sloan Kettering Arvin S. Geicksman, MD - Sloan Kettering Organization: This research was conducted by the Sloan Kettering Institute for Cancer Research. The work was initially supported under U.S. Army contracts DA-49-007-MD-533 and DA-49-007-MD-669 and then supported by the Armed Forces Special Weapons Project (AFSWP) contract DA-49-146-XZ-037. Subject: The subjects were patients at the SKICR all with widespread cancer. Twenty-two patients received total body irradiation (TBI) and 12 received radiation to the head for treatment of tumors. The subjects are identified by initials, types of cancer, and, in some cases, by age and sex. The population was 3:1 female to male with ages from 19 to 63 with an average age of 47 years. Purpose: Available reports have been reviewed. The patient selection required that patients with radiation sensitive lesions be excluded. The aim of the study was to evaluate the efficacy of radiation in the treatment of widely spread cancers that were intractable to treatment. The investigators did observe whole body effects on the patients but that was secondary to the evaluation of radiation as a treatment modality. Since the primary intent of the study was to treat cancer and provide a direct benefit to the subjects, apparently the Nuremberg Code and the Declaration of Helsinki were complied with. The radiation source was commonly a Van de Graaf generator. Doses ranged from 50 to 150R for the TBI and up to 4000R was used for irradiation of localized cancers. In addition to the cancer treatment information, data was collected on: clinical observations, hematologic parameters, plasma protein distribution, urine excretion, and electroencephalograms. These observations were reported to the AFSWP. There is no record of clinical follow-up beyond the 75 day post exposure period (the greatest reported period). Records: Currently identified records are the reports submitted to the AFSWP by the SKICR. The titles and dates on the reports indicate that certain reports are missing; the missing reports are being sought for review. Prepared by: CAPT C. B. GALLEY, AFRRI, ((310)-295-1048)