Including persons with HIV infection in cancer clinical trials

Journal of Clinical Oncology

Volumn 26, Issue 7, 2008, Pages 1027-1032

  Persad, Govind C ^a   Little, Richard F ^a   Grady, Christine ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTINEOPLASTIC AGENT; ANTIRETROVIRUS AGENT; CD4 ANTIGEN; CYTOTOXIC AGENT; IMMUNOSUPPRESSIVE AGENT;

BONE MARROW SUPPRESSION; CANCER RISK; CANCER SURVIVAL; CD4 LYMPHOCYTE COUNT; DRUG SAFETY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; NOTE; PRIORITY JOURNAL; CLINICAL TRIAL; METHODOLOGY; NEOPLASM; PATIENT PARTICIPATION; REVIEW;

CLINICAL TRIALS AS TOPIC; HIV INFECTIONS; HUMANS; NEOPLASMS; PATIENT PARTICIPATION; RESEARCH DESIGN;

EID: 41949099556     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.14.5532     Document Type: Note

References (50)

1. Rothman K, Greenland S: Validity and generalizability in epidemiologic studies, in Armitage P, Colton T (eds): Encyclopedia of Biostastatistics. Chichester, J Wiley & Sons, 1988, pp 4694-4706
2. CIOMS: The international guidelines for biomedical research involving human subjects. Geneva, Switzerland, CIOMS, 2002
3. Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 283:2701-2711, 2000
4. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC, United States Department of Health and Human Services, 1979
5. FDAMA Women and Minorities Working Group: FDAMA: Women and Minorities Guidance Requirements. http://www.fda.gov/CDER/guidance/women.pdf
6. Food and Drug Administration Center for Drug Evaluation and Research: How to Comply with the Pediatric Research Equity Act. http://www.fda.gov/CbER/ gdlns/pedreseq.pdf
7. National Institutes of Health Office of Extramural Research: NIH policy and guidelines on the inclusion of children as participants on research involving human subjects. Bethesda, MD, National Institutes of Health, 1998
8. National Institutes of Health Office of Extramural Research: NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Bethesda, MD, National Institutes of Health, 2001
9. National Cancer Institute Cancer Therapy Evaluation Program: Guidelines regarding the inclusion of cancer survivors and HIV-positive individuals on clinical trials. Bethesda, MD, National Cancer Institute, 2006
10. Centers for Disease Control and Prevention: HIV/AIDS surveillance report, 2004. Atlanta, GA, Department of Health and Human Services, Centers for Disease Control and Prevention, 2005
11. Lohse N, Hansen A-BE, Pedersen G, et al: Survival of persons with and without HIV iInfection in Denmark, 1995-2005. Ann Intern Med 146:87-95, 2007
12. Bonnet F, Lewden C, May T, et al: Malignancy-related causes of death in human immunodeficiency virus-infected patients in the era of highly active antiretroviral therapy. Cancer 101:317-324, 2004
13. Burgi A, Brodine S, Wegner S, et al: Incidence and risk factors for the occurrence of non-AIDS-defining cancers among human immunodeficiency virus-infected individuals. Cancer 104:1505-1511, 2005
14. Epstein S: Impure Science: AIDS, Activism, and the Politics of Knowledge. Berkeley, CA, University of California Press, 1996
15. Nelson R: AIDS treatment enters its 25th year. Lancet Infect Dis 6:466-467, 2006
16. Engels EA, Brock MV, Chen J, et al: Elevated incidence of lung cancer among HIV-infected individuals. J Clin Oncol 24:1383-1388, 2006
17. Yarchoan R, Tosato G, Little RF: Therapy insight: AIDS-related malignancies - The influence of antiviral therapy on pathogenesis and management. Nat Clin Pract Oncol 2:406-415, 2005
18. Adams-Campbell LL, Ahaghotu C, Gaskins M, et al: Enrollment of African Americans onto clinical treatment trials: Study design barriers. J Clin Oncol 22:730-734, 2004
19. Little RF, Pittaluga S, Grant N, et al: Highly effective treatment of acquired immunodeficiency syndrome-related lymphoma with dose-adjusted EPOCH: Impact of antiretroviral therapy suspension and tumor biology. Blood 101:4653-4659, 2003
20. National Cancer Institute: Physician Data Query (PDQ) Cancer Clinical Trials Registry. Accessed 2007. http://www.cancer.gov/clinicaltrials/search
21. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2006. CA Cancer J Clin 56:106-130, 2006
22. Lewden C, Salmon D, Morlat P, et al: Causes of death among HIV-infected adults in the era of potent antiretroviral therapy: Emerging role of hepatitis and cancers, persistent role of AIDS. Int J Epidemiol 34:121-130, 2005
23. NAM: Lung Cancer factsheet. http://www.nam.org.uk/en/docs/pdf/fs101.pdf5
24. AEGiS-CATIE News: Lung cancer in HIV positive HAART-users - February 6, 2003. http://www.aegis.com/news/catie/2003/CATE-N20030201.html
25. Antinori A, Cingolani A, Alba L, et al: Better response to chemotherapy and prolonged survival in AIDS-related lymphomas responding to highly active antiretroviral therapy. Aids 15:1483-1491, 2001
26. Sparano JA, Lee S, Chen MG, et al: Phase II trial of infusional cyclophosphamide, doxorubicin, and etoposide in patients with HIV-associated non-Hodgkin's lymphoma: An Eastern Cooperative Oncology Group trial (E1494). J Clin Oncol 22:1491-1500, 2004
27. Glynn M, Rhodes P: Estimated HIV prevalence in the United States at the end of 2003. National HIV Prevention Conference, Atlanta, GA, June 12-15, 2005 (abstr T1-B1101)
28. Manheimer E, Anderson D: Survey of public information about ongoing clinical trials funded by industry: Evaluation of completeness and accessibility. BMJ 325:528-531, 2002
29. Ohno-Machado L, Wang SJ, Mar P, et al: Decision support for clinical trial eligibility determination in breast cancer. Proc AMIA Symp 340-344, 1999
30. Herida M, Mary-Krause M, Kaphan R, et al: Incidence of non-AIDS-defining cancers before and during the highly active antiretroviral therapy era in a cohort of human immunodeficiency virus-infected patients. J Clin Oncol 21:3447-3453, 2003
31. Apseloff G: HIV testing in early clinical trials: Who should decide whether it is warranted? J Clin Pharmacol 42:601-604, 2002
32. Mackall CL, Fleisher TA, Brown MR, et al: Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood 84:2221-2228, 1994
33. Kaplan LD, Lee JY, Ambinder RF, et al: Rituximab does not improve clinical outcome in a randomized phase III trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin's lymphoma: AIDS-malignancies consortium trial 010. Blood 106:1538-1543, 2005
34. Devine PG, Plant EA, Harrison K: The problem of "us" versus "them" and AIDS stigma. Am Behav Sci 42:1212-1228, 1999
35. Werth JL, Lord CG: Previous conceptions of the typical group member and the contact hypothesis. Basic Appl Soc Psych 13:351-369, 1992
36. Levine C, Faden R, Grady C, et al: The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth 4:44-49, 2004
37. Weijer C: Selecting subjects for participation in clinical research: One sphere of justice. J Med Ethics 25:31-36, 1999
38. Rauner MS, Brandeau ML: AIDS policy modeling for the 21st century: An overview of key issues. Health Care Manag Sci 4:165-180, 2001
39. Halpern SD, Ubel PA, Caplan AL: Solid-organ transplantation in HIV-infected patients. N Engl J Med 347:284-287, 2002
40. Abbott KC, John SS, Agodoa LYC, et al: Human immunodeficiency virus infection and kidney transplantation in the era of highly active antiretroviral therapy and modern immunosuppression. J Am Soc Nephrol 15:1633-1639, 2004
41. Wyatt CM, Murphy B: Kidney transplantation in HIV-infected patients. Semin Dial 18:495-498, 2005
42. Balsalobre P, Serrano D, Carrion R, et al: Comparative study of autologous stem cell transplant (ASCT) in HIV-1 positive (HIV+) on HAART and HIV-1 negative (HIV-) Hodgkin lymphoma (HD) patients. Presented at the 32nd Annual Meeting of the European Group for Blood and Marrow Transplantation, Hamburg, Germany, March 19-22, 2006
43. Kang EM, de Witte M, Malech H, et al: Nonmyeloablative conditioning followed by transplantation of genetically modified HLA-matched peripheral blood progenitor cells for hematologic malignancies in patients with acquired immunodeficiency syndrome. Blood 99:698-701, 2002
44. Krishnan A, Molina A, Zaia J, et al: Durable remissions with autologous stem cell transplantation for high-risk HIV-associated lymphomas. Blood 105:874-878, 2005
45. Fishman JA: Transplantation for patients infected with human immunodeficiency virus: No longer experimental but not yet routine. J Infect Dis 188:1405-1411, 2003
46. Qiu J, Terasaki PI, Waki K, et al: HIV-positive renal recipients can achieve survival rates similar to those of HIV-negative patients. Transplantation 81:1658-1661, 2006
47. Spital A: Should all human immunodeficiency virus-infected patients with end-stage renal disease be excluded from transplantation? The views of U.S. transplant centers. Transplantation 65:1187-1191, 1998
48. National Cancer Institute Cancer Therapy Evaluation Program: Phase II single agent template, version 4.0. Bethesda, MD, National Cancer Institute, 2006
49. Read T, Mijch A, Fairley CK: Adherence to antiretroviral therapy: Are we doing enough? Intern Med J 33:254-256, 2003
50. Masur H, Kaplan JE, Holmes KK: Guidelines for preventing opportunistic infections among HIV-infected persons-2002: Recommendations of the US Public Health Service and the Infectious Diseases Society of America. Ann Intern Med 137:435-478, 2002