AIDS-ASSOCIATED KAPOSI'S SARCOMA NIH GUIDE, Volume 21, Number 17, May 8, 1992 PA NUMBER: PA-92-76 P.T. 34 Keywords: AIDS Cancer/Carcinogenesis Pharmacology Biological Response Modifiers Growth Factors National Cancer Institute National Institute of Allergy and Infectious Diseases PURPOSE The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI) and the Division of Acquired Immunodeficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) invite applications from interested investigators to perform innovative correlative laboratory studies of relevance to new and ongoing AIDS- Kaposi's sarcoma clinical trials or to develop new therapies for the treatment of AIDS-Kaposi's sarcoma with laboratory correlations. This Program Announcement (PA) is designed to promote collaborations and interactions among researchers from a variety of basic and clinical disciplines to facilitate better treatment and management of AIDS- Kaposi's sarcoma patients. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, AIDS- Associated Kaposi's Sarcoma, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) Award. Applications from minority individuals and women are encouraged. Applications from single or multiple institutions (individual institutions consortia, and cancer centers) with established clinical, laboratory, and statistical resources are encouraged. MECHANISM OF SUPPORT Awards will be made as investigator-initiated research grants (R29, R01 and interactive R01s) in accordance with PHS policies applicable to research project grants. A description of an interactive R01 application is published in the NIH Guide (Vol. 21, No. 1, January 10, 1992) under PA-92-29. Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No.(OASH) 90-50,000, revised October 1, 1990. RESEARCH OBJECTIVES Summary Kaposi's Sarcoma (KS) is one of the malignancies most frequently seen in AIDS patients; however, the etiology of KS in AIDS patients remains unclear. The precise relationship of KS to the underlying immunodeficient state in patients with HIV infection also remains unclear. The most prominent clinical feature of KS in HIV-positive patients is the aggressiveness of the disease. KS in AIDS patients is associated with extensive involvement of skin and mucous membranes, early dissemination to lymph nodes, impressive development of extreme lymphedema, even in the absence of bulky adenopathy, and rapid spread to visceral organs, including lungs and gastrointestinal tract. Although rapid clinical progression and short median survival have been the rule, some patients have survived for many years with disease limited to the skin. Certain clinical and laboratory features, such as presence of unexplained fever, night sweats, weight loss, and significant T4 lymphocytopenia, have been identified as indicators of poor prognosis. Various therapeutic interventions have been employed resulting in partial and complete remissions but with no significant improvement in the survival of these patients. High-dose recombinant interferon alpha has produced response rates in approximately 30 percent of treated patients. Likewise, vinblastine has produced similar response rates. Both of these therapies have substantial toxic side effects. The purpose of this PA is to foster collaborative interactions between laboratory scientists and clinicians to precisely characterize the molecular and genetic characteristics of AIDS- Kaposi's Sarcoma or to devise more effective management of this disease. Laboratory research efforts and novel therapies ready to be applied in clinical situations and innovative clinical applications are solicited. It is hoped that the results obtained from studying AIDS- Kaposi's sarcoma patients will increase the understanding of the biology of this disease and will assist the development of more effective treatment in the general population of KS patients and patients with other proliferative diseases. Some examples of clinical studies and their correlative laboratory studies that would qualify are: (l) pharmacokinetic and pharmacodynamic measurements leading to novel means of combining retroviral and antitumor therapies; (2) biological response modifiers in combination with cytotoxic and radiation therapy with immune function studies; (3) molecular characterization of oncogenes and growth factors for the development of new anti-growth factor or anti- sense therapies. Investigators are not limited to the above examples of potential studies. Other scientific approaches may be proposed. The NCI recognizes that research in AIDS-Kaposi's sarcoma is technically difficult to conduct because of the complexity of this disease and the relatively limited availability of study subjects at any single institution. Thus, the NCI is encouraging the submission of grant applications for research relevant to this PA in the context of multi-institutional efforts under the interactive R01 mechanism (see PA-92-29). Objectives The aims of this initiative are two-fold: (1) to support innovative correlative laboratory studies relevant to AIDS-Kaposi's Sarcoma clinical trials and (2) to stimulate development of innovative AIDS- Kaposi's sarcoma clinical studies with laboratory correlations so as to foster the development of interactions between basic science laboratories and clinicians performing these clinical trials. STUDY POPULATION SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in the Research Plan, 1-4 AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the deadlines as indicated in the application kit for AIDS-related research (January 2, May 1, and September 1). Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific- technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Roy S. Wu Program Director, Cancer Therapy Evaluation Program Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Dr. Giorgio Galetto NIAID Program Director National Institute of Allergy and Infectious Diseases Control Data Building, Room 2C32 Bethesda, MD 20892 Telephone: (301) 496-0700 FAX: (301) 480-5703 Direct inquiries regarding fiscal matters to: Ms. Carolyn Mason Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 59 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395 Cancer Treatment Research No. 93.855, Immunology, Allergy, and Immunologic Research, and No. 93.856, Microbiology and Infectious for Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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