Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
This randomized phase III trial studies imiquimod or fluorouracil to see how well they work
compared to observation in treating patients with high-grade anal squamous skin lesions who
are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may
stimulate the immune system in different ways and stop tumor cells from growing. Drugs used
in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. It is not yet known
whether imiquimod or fluorouracil is more effective than observation in treating high-grade
anal squamous skin lesions.
Phase:
Phase 3
Details
Lead Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI) The Emmes Company, LLC The EMMES Corporation University of Arkansas