Final Report of Human Radiation Research (List of 231 Enclosures)

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DEPARTMENT OF THE NAVY SAN DIEGO CALIFORNIA921345000IN REPLY REFER TO From: Commander, Naval Medical Center, San Diego To: Chief, Bureau of Medicine and Surgery, (MED-21), 2300 E Street, Northwest, Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH Ref: (a) BUMED 0101252 Feb 94 List of National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocols in which NMCSD Patients Participated Experimental Protocol Summary Entitled: The Significance of Positive Ipsilateral Nodes in Resections of Lung Experimental Protocol Summary Entitled: Chemotherapeutic Agents in the Treatment of Lung Tumors Experimental Protocol Summary Entitled: Extracranial Suspension vs Inter- or Intraosseus Support in Treatment of Facial Fracture Experimental Protocol Summary Entitled: Pancreato-Cholangiography and Manometry of the Sphincter Odi Experimental Protocol Summary Entitled: Results of Clubfoot Treatment Experimental Protocol Summary Entitled: Colonoscopy in the Differential Diagnosis Inflammatory Bowel Disease Experimental Protocol Summary Entitled: Stress Fractures of the Femur Experimental Protocol Summary Entitled: Ketamine Anesthesia in Minor Experimental Protocol Summary Entitled: Immunocyto-adherence Testing in Experimental Protocol Summary Entitled: Treatment of Tibial Fractures with Experimental Protocol Summary Entitled: Early Diagnosis of Aseptic Necrosis of the Femoral Head Following Traumatic Dislocation of the Hip Experimental Protocol Summary Entitled: Acromio-Clavicular Separations Experimental Protocol Summary Entitled: Use of Non-Invasive Monitoring Technique to Evaluate the Pre- and Post-Operative Arterial Blood Flow A-S-0 Experimental Protocol Summary Entitled: Endoscopic Electrosurgical Experimental Protocol Summary Entitled: Recurrent Lower Urinary Tract Infections in Women: The Effect of Urethral Dilation Experimental Protocol Summary Entitled: Angiographic Analysis of Left Ventricular Mechanics in Young Patients with Atypical Chest Pain and Ischemic

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Subj: FlNAL REPORT OF HUMAN RADIATION RESEARCH Experimental Protocol Summary Entitled: Fracture of the Ankle in a Military Experimental Protocol Summary Entitled: Abnormalities Involving the Alternate Pathway in Urticaria or Angioedema Experimental Protocol Summary Entitled: NSABP B-10: A Clinical Trial to Compare Combination Chemotherapy and Without C. Parvum in the Management of Patients with Surgically Curable Breast Cancer Who have One or More Axillary Nodes Experimental Protocol Summary Entitled: Detection of a Pericardial Effusion by Echocardiography in Hypothyroid Patients Experimental Protocol Summary Entitled: The Use of *Tc-Pyrophosphate Bone Scanning in the Early Detection of Stress Fractures Experimental Protocol Summary Entitled: Bone and Gallium Scanning in the Evaluation of Disseminated Coccidiomycosis Experimental Protocol Summary Entitled: NSABP# 4 Experimental Protocol Summary Entitled: The Distribution of Ventilatioflerfusion Ratios in Acute and Chronic Cardiopulmonary Disease Experimental Protocol Summary Entitled: Effect of Hyperthyroidism on Serum Gastrin and Gastric Acid Production Before and After Treatment Experimental Protocol Summary Entitled: Vasodilated Excretory Urography - A Diagnostic Approach to Renovascular Hypertension Experimental Protocol Summary Entitled: Contrast Media Reactions - The Role of Histamine, Complement and Dilutional Skin Tests Experimental Protocol Summary Entitled: Pilot Study for the Treatment of Previously Untreated Brain Tumor in Children Experimental Protocol Summary Entitled: Combination Chemotherapy of Disseminated Testicular Carcinoma with Cis-Diaminodichloroplatinum with Experimental Protocol Summary Entitled: NSABP R-01: A Clinical Trial to Evaluate Post-operative Radiation and Post-operative Systemic Chemotherapy in the Management of Resectable Rectal Carcinoma Experimental Protocol Summary Entitled: NSABP C-1: A Clinical Trial to chemotherapy in the Management of Resectable Colon Cancer Experimental Protocol Summary Entitled: A Comparison of Three Iodinated Contrast Media for Excretory Urography Experimental Protocol Summary Entitled: The Efficacy of Corticosteroid in the Treatment of Acute Asthma Experimental Protocol Summary Entitled: The Usefulness of Computerized Axial Tomography in Evaluation of Pulmonary Metastases Experimental Protocol Summary Entitled: Adjuvant Immunotherapy in Stage I Non-Oat Cell Lung Carcinoma

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH Experimental Protocol Summary Entitled: Bone Scanning in the Evaluation of Experimental Protocol Summary Entitled: Treatment of Lower Respiratory Tract Infection with Ceforanide vs Cefazolin Experimental Protocol Summary Entitled: Evaluation of a New Cefalosporin, Hr -756, in the Treatment of Infections Caused by Susceptible Bacteria Experimental Protocol Summary Entitled: Phase In Clinical Investigation of Indium DTPA for Cisternography Experimental Protocol Summary Entitled: Evaluation of Ketoconazole in the Treatment of Systemic Mycoses Experimental Protocol Summary Entitled: Controlled Study on the Use of Dopamine in Neonatal Asphyxia Experimental Protocol Summary Entitled: An Evaluation of Profile Changes Following Vestibuloplasty Techniques Experimental Protocol Summary Entitled: National Study of Contrast Media Experimental Protocol Summary Entitled: A Quantitative Assessment of Facial Soft Tissue Response Following the Use of Methylprednisolone After Singular Orthognathic Surgical Procedures Experimental Protocol Summary Entitled: Ventilatory Function After Flail Experimental Protocol Summary Entitled: Combination Chemotherapy of Diffuse Malignant Pleural Mesothelioma with Ether Adriamycin and Cytoxan or Cytoxan, Oncovin, Methotrexate and 5-Fluorouracil Experimental Protocol Summary Entitled: Radionuclide Biliary Imaging Experimental Protocol Summary Entitled: Ventilation Changes ResuIting From Drainage and Pleurodesis for Malignant Pleural Effusion Experimental Protocol Summary Entitled: Terminal Deoxynucleotidyl Transferase (TdT) Immunofluorescence of Bone Marrow Smears Experimental Protocol Summary Entitled: CALGB 8082: Surgical Adjuvant Chemotherapy of Stage II Breast Cancer: Two CMFVP Regimens with or without a Subsequent Adriamycin Combination Experimental Protocol Summary Entitled: NSABP B-06: A Protocol to Compare Segmental Mastectomy and Axillary Dissection with and without Radiation of the Breast and Total Mastectomy and Axillary Dissection Experimental Protocol Summary Entitled: NSABP B-1 1: A Protocol to Adriamycin in the Management of Patients with Primary Breast Cancer and Positive Axillary Nodes Whose Tumors Are Negative For Estrogen Receptors

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH Experimental Protocol Summary Entitled: NSABP B-12: A Protocol to without Adriamycin in the Management of Patients with Primary Breast Cancer and Positive Axillary Nodes Whose Tumors Are Positive for Estrogen Receptors Experimental Protocol Summary Entitled: A Randomized Controlled Trial of Indomethacin, PGI,, and Heparin in the Acute Phase of Cerebral Ischemia Experimental Protocol Summary Entitled: Radionuclide Biliary Imaging Experimental Protocol Summary Entitled: A Double-blind Controlled Study Comparing Indomethacin and Placebo in Prevention of Radiation Esophagitis Experimental Protocol Summary Entitled: Combination Chemotherapy, Whole -Body Radiotherapy and Non-Cross Resistant Chemotherapy for Small Cell Carcinoma of the Lung, Extensive Disease Experimental Protocol Summary Entitled: A Comparative Study of Cefadroxil vs. Cephalexin in the Treatment of Bacterial Pneumonia in Ambulatory Patients Experimental Protocol Summary Entitled: Serial Angiographic Assessment of the Effect of Risk Factor Modification in Young Active Duty Navy Men Experimental Protocol Summary Entitled: Establishment of Radioimmunoassay for Measuring Human Immunoglobulin Experimental Protocol Summary Entitled: CALGB 775 1: The Comparative Effectiveness of Combination Chemotherapy Alone or with Radiation Therapy to Involved Field or Extended Field, in Poor Risk Patients with Stage I and II Experimental Protocol Summary Entitled: CALGB 776 1: Combination Chemotherapy of Multiple Myeloma Experimental Protocol Summary Entitled: Protocol for Clinical Evaluation of Percutaneous Coronary Angioplasty Experimental Protocol Summary Entitled: Use of VP16-213 in Combination with Cisplatin for Treatment of Recurrent Testicular Cancer in a Single Patient Experimental Protocol Summary Entitled: Emergency Use of Investigational Experimental Protocol Summary Entitled: CALGB-7982: Chemotherapy of Advanced Pancreatic Cancer - A Comparative Phase 11 Study Experimental Protocol Summary Entitled: CALGB-8011: A Study of the Effectiveness of Intensification with Two Courses of Cytosin Arabinoside and Daunorubicin Following Remission Induction with Acute Lymphocytic Experimental Protocol Summary Entitled: CALGB-808 1: A Randomized Study Comparing the Combination of Hormonal Therapy and Chemotherapy with Chemotherapy Alone for the Treatment of Advanced Breast Cancer in Women

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH Experimental Protocol Summary Entitled: CALGB-8082: Surgical Adjuvant Chemotherapy of Stage II Breast Cancer; Two CMFVP Regimens with or without a Subsequent Adriamycin Combination Experimental Protocol Summary Entitled: CALGB-8083: Localized Small Cell Carcinoma of the Lung - A Phase II Study of Simultaneous Chemotherapy and Radiotherapy vs Sequential Therapy vs Chemotherapy Alone Experimental Protocol Summary Entitled: CALGB-8 121: A Comparative Study of High Dose Ara-C Alone or Given Sequentially with L-Asparaginase for Remission Induction in Patients with Acute Myelogenous Leukemia After Failure of Initial Induction or in Relapse Experimental Protocol Summary Entitled: CALGB-8 143: Vinblastine, DTIC, and Cis-Platinum (DDP) in the Treatment of Advanced or Recurrent Metastatic Experimental Protocol Summary Entitled: CALGB-8 144: Therapy of Chronic Myelogenous Leukemia in Blast Crisis with 5-Azacytidine Plus VP- 16-213 Experimental Protocol Summary Entitled: NSABP B-13: A Clinical Trial to Assess Sequential Methotrexate + 5-Fluorouracil in Patients with Primary Breast Cancer and Negative Axillary Nodes Whose Tumors are Negative for Estrogen Experimental Protocol Summary Entitled: NSABP B-14: A Clinical Trial to Assess Tamoxifen in Patients with Primary Breast Cancer and Negative Axillary Nodes Whose Tumors are Positive for Estrogen Receptors Experimental Protocol Summary Entitled: CALGB-7784: Combination Chemotherapy with Mastectomy or Radiotherapy for Stage I11 Breast Experimental Protocol Summary Entitled: Continuous Infusion Vinblastine with Bleomycin and Cisplatin for Treatment of Cancers of the Upper Digestive Tract Experimental Protocol Summary Entitled: Evaluation of Light Scanning as a New Modality for Screening Women for Breast Cancer Experimental Protocol Summary Entitled: A Phase II Trial of Three Drug Regimen Consisting of Cytoxan, 5-FU, and Cis-Platinum in Stage D Adenocarcinoma of the Prostate Experimental Protocol Summary Entitled: POG#7898: Intergroup Hodgkin’s Lymphoma in Children Experimental Protocol Summary Entitled: Intermittent High Dose Cytarabiner for Treatment of Colorectal Adenocarcinoma: A Phase I1 Study Experimental Protocol Summary Entitled: Stress Fracture as the Etiology of Acute Chondromalacia, Patella

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH Experimental Protocol Summary Entitled: A Comparative Study of Two Remission Induction Regimens of A Ra-C for Acute Myelogenous Leukemia: A Phase III Study Experimental Protocol Summary Entitled: Treatment of Advanced Hodgkin’s Disease: A Randomized Phase III Trial Comparing MOPP vs. ABVD vs. MOPP Alternating with ABVD Experimental Protocol Summary Entitled: Emergency use of CIS-Platinum (DDP), Vindesine (DVA), and Bleomuycin in the Treatment of Esophageal Experimental Protocol Summary Entitled: Therapy of CML in Blast Crisis Experimental Protocol Summary Entitled: Combination Chemotherapy for Metastatic Recurrent Cancer of the Breast. A Randomized Phase I11 Trial Comparing CAF VATH vs. VATH Alternating with CMFVP Experimental Protocol Summary Entitled: CALGB-8243: A Randomized Phase II Trial of Cytosine Arabinoside (ARA-C) and Platinum (CDDP) vs. Vinblastine (VLG) and Platinum (CDDP) in Advanced Non-Small Cell Lung Experimental Protocol Summary Entitled: The Effect of Verapamil on Patients with Irritable Bowel Syndrome who have Diarrhea with or without Abdominal Experimental Protocol Summary Entitled: Computed Tomography and Peritoneal Lavage in Determining the Severity of visceral Injury after Blunt Experimental Protocol Summary Entitled: Phase I Study of Indium-1 11 labeled Murine Monoclonal Antibody for External Photoscanning of Melanoma and Experimental Protocol Summary Entitled: Nonalcoholic Liver Disease in the Experimental Protocol Summary Entitled: Indium- 1 11 Oxine Labeled Granulocytes for Detection of Inflammatory Process in Humans Experimental Protocol Summary Entitled: The Use of Isotretinoin in Prevention of Basal Cell Carcinoma Experimental Protocol Summary Entitled: NSABP B-04: Protocol for the Evaluation of Radical Mastectomy and Total Mastectomy with and without Radiation in the Primary Treatment of Cancer of the Female Breast Experimental Protocol Summary Entitled: NSABP B-07: A Clinical Trial to Compare L-PAM with L-PAM and 5-FUin the Management of Primary Breast Cancer who Have One or More Positive Nodes

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH (99) Experimental Protocol Summary Entitled: NSABP B-08: A Clinical Trial to Management of Patients with Primary Breast Cancer Who Have One or More Positive Axillary Nodes (100) Experimental Protocol Summary Entitled: Emergency Drug Use of Investigational Drug AZQ IC0 Theresa Fousel (101) Experimental Protocol Summary Entitled: Approval of the Final Case Report on the Emergency Use of Investigational Drugs Methyl-GAG and Ifosphamide (102) Experimental Protocol Summary Entitled: CALGB-8431: Carboplatin -(103) Experimental Protocol Summary Entitled: CALGB-8433: Regional Stage 111 NSCLC Chemotherapy and Radiation Therapy vs. Radiation Therapy Alone (104) Experimental Protocol Summary Entitled: Mitomycin and Cisplatin vs. Adriamycin and Cisplatin for Malignant Mesothelioma Phase 11 (105) Experimental Protocol Summary Entitled: Cystosine Arabinoside and Cisplatin for Advance Stage Breast Cancer (106) Experimental Protocol Summary Entitled: Cold Cardioplegia - Effects on Phrenic Nerve Conduction, Diaphragm Motion and Lung Volumes (107) Experimental Protocol Summary Entitled: Diagnostic Utility of Bone Scans in Sarcoidosis and Correlation of Bone Involvement with Disease Activity (108) Experimental Protocol Summary Entitled: CALGB 8531: Adjuvant CDF for Pathologic Stage II Breast Cancer: Randomization Among Intensive CDF for Four Months vs. Standard Dose CDR for Six Months (109) Experimental Protocol Summary Entitled: NSABP B-15: Three Arm Clinical Trial Comparing Short Intensive Adriamycin-Cyclophosphamide with or without Interval Reinduction Chemotherapy (CMF) to Conventional Chemotherapy (CMF) in Positive Node Patients Who are Ages 49 or Younger Six Months Trial Comparing Tamoxifen Alone with Short Intensive AdriamycinCyclophosphamide + Tamoxifen in Positive Patients with Positive Progesterone Assays Who are Aged 50 to 59 or Greater than 59 Regardless of PR Status Protocol for Intermediate Thickness Melanomas 1.0 to 4.0mm Emergency Use of Investigational Drug Cyanoacrylate Investigational Procedure I C 0 Mckinley Wright (1 10) Experimental Protocol Summary Entitled: NSABP B-16: Three Arm Clinical (1 11) Experimental Protocol Summary Entitled: MEL 82-323: National Intergroup (1 12) Experimental Protocol Summary Entitled: Approval of the Final Report on the (1 13) Experimental Protocol Summary Entitled: One Time Emergency Use of (1 14) Experimental Protocol Summary Entitled: Emergency Use of VM-26 I C 0 Y. (1 15) Experimental Protocol Summary Entitled: Non-Emergency Use of an

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH (1 16) Experimental Protocol Summary Entitled: Comparison of Four Methods of (1 17) Experimental Protocol Summary Entitled: Treatment of Calcinosis (1 18) Experimental Protocol Summary Entitled: One Time Use of Investigational (1 19) Experimental Protocol Summary Entitled: Fever and Bacteremia Following Measuring Extension of the Lumbar Spine Circumscripta with Probecid - A Pilot Study Drug, Absolute Alcohol, on a Single Patient I C 0 Brenda L. Fenin Bronchoscopy: A Prospective Study to Determine Frequency, Source of Bacteria, and Implications for Endocarditis Prophylaxis Evaluate Natural History and Treatment of Patients with Non-Invasive (122) Experimental Protocol Summary Entitled: Phase I11 Trial of Intensive Treatment for Adult Acute LL: A Comparison of Combination Chemotherapy Plus Alternating Mitoxantrone and Daunorubicin vs. Combination Chemotherapy Experimental Protocol Summary Entitled: Echinomycin for Advanced Breast Cancer: A Phase I1 Study Experimental Protocol Summary Entitled: POG 8304: combination Chemotherapy for Remission Induction and Maintenance for 1) Recurrent CLL Occumng 6 Months or Greater After Elective Cessation of Therapy - Hodgkin’s Lymphoma and 2) Children with Occult Testicular LL After 3 Years of Continuous Complete Remission ( 1 25) Experimental Protocol Summary Entitled: Utility of Endoscopy for X-ray Negative Dysphagia: A Prospective Analysis (126) Experimental Protocol Summary Entitled: Management Strategies Based on Risk After Acute Myocardial Infarction (127) Experimental Protocol Summary Entitled: CALGB 865 1: Trimexatrate (NSC #352 122) for Non-Hodgkin’s Lymphoma: Phase II (1 28) Experimental Protocol Summary Entitled: CALGB 8534: Combination Chemotherapy with Intensive ACERCE and Radiation Therapy to the Primary Tumor and Prophylactic Whole Brain Radiation Therapy with or without Warfarin in Limited Small Cell Carcinoma of the Lung: Phase 111 Experimental Protocol Summary Entitled: CALGB 866 1: The Epidemiology of Acute Leukemias in Adults with Special Reference to Cytogenetically Experimental Protocol Summary Entitled: CALGB 8695: Combination Chemotherapy for Advanced Hodgkin’s Disease (1 20) Experimental Protocol Summary Entitled: Investigational Agent Status Report (121) Experimental Protocol Summary Entitled: NSAPB B-17: A Clinical Trial to

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Subj: FINAL REPORT OF HUMAN RADIATION RESEARCH (13 1) Experimental Protocol Summary Entitled: CALGB 8691: Cyclophosphamide vs Cyclophosphamide Plus Alpha-2 Interferon in the Treatment of Follicular, Low Grade Lymphomas: Phase 111 Study Single Agent Induction Chemotherapy vs Standard Chemotherapy for Stage IV Breast Carcinoma - Phase 111 Interleukin-:! and B-Interferon for Relapse or Refractory Lymphoma - A Limited Access Phase I1 Study (134) Experimental Protocol Summary Entitled: CALGB 8741: A Dose Response Trial …