This application is in response to the RFA for innovative therapeutic studies in Acquired Immunodeficiency Syndrome (AIDS) malignancies. The studies proposed meet the objectives outlined in Healthy People 2000 in the areas of cancer and AIDS in women and minority groups and will be performed by the member institutions of the Gynecologic Oncology Group, a multidisciplinary, multimodality cooperative clinical trial organization composed of 50 full member and 150 affiliate member universities or large community hospitals in North America with designated programs in the design and conduct of new anti-cancer therapies for women with pelvic malignancies. The recent recognition that HIV infection and cervical cancer identified a new form of AIDS has led to the need for and the development of treatment programs. This application describes, as the first step in a program of clinical trials, an innovative Phase II study intended to strengthen the immune system while delivering anti- cancer therapy. This study will be followed by others testing the improved regimen in related groups: those with cervical intraepithelial neoplasia (CIN) and those with cervical cancer but without HIV infection as controls. Appropriate laboratory specimens will be collected and distributed to qualified laboratories in order to enhance present-day knowledge of the biological manifestations of the combination of HIV infection and cancer.
