Surgery for Anal Cancer in HIV/AIDS Patients
Trial Summary
What is the purpose of this trial?
This trial studies surgery to treat patients with small anal or perianal cancer who also have HIV. The surgery aims to safely remove the cancer with fewer side effects compared to other treatments. By cutting out the cancer, it helps prevent it from spreading or returning.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that ongoing use of certain anticoagulant therapies (blood thinners) other than aspirin or NSAIDs must be stopped for surgical procedures. If you are on systemic chemotherapy or radiation therapy that affects bone marrow, it may also need to be stopped.
Is surgery for anal cancer safe in HIV/AIDS patients?
The safety of surgery for anal cancer in HIV/AIDS patients is not well-documented in the available research, which mainly focuses on chemoradiotherapy. There is some uncertainty about increased toxicity and adverse effects on the immune system with standard treatments, but specific safety data for surgery alone is lacking.12345
How does the treatment 'Therapeutic Conventional Surgery' for anal cancer in HIV/AIDS patients differ from other treatments?
Therapeutic Conventional Surgery for anal cancer in HIV/AIDS patients is unique because it involves a surgical approach, whereas the standard treatment for anal cancer typically involves chemoradiotherapy, which combines chemotherapy and radiation to preserve anal function and avoid more invasive surgery. This surgical method may be considered when chemoradiotherapy is not effective or suitable.46789
Research Team
Stephen Goldstone
Principal Investigator
AIDS Associated Malignancies Clinical Trials Consortium
Eligibility Criteria
Adults with early stage anal canal or perianal cancer and HIV can join this trial. They should have a certain level of white blood cells, no history of other cancers, and be able to follow the study plan. Pregnant women can't participate, and men must use birth control if they could father a child.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication.
Follow-up
Participants are monitored for treatment failure and adverse events every 3 months for 36 months.
Specimen Collection
Collection of clinical specimens for correlative science to assess viral and host factors in HSIL progression to cancer.
Treatment Details
Interventions
- Therapeutic Conventional Surgery
Therapeutic Conventional Surgery is already approved in United States, European Union for the following indications:
- Resectable p16+ Locally Advanced Oropharynx Cancer
- HPV-positive oropharyngeal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
AIDS and Cancer Specimen Resource
Collaborator
University of Arkansas
Collaborator
National Cancer Institute (NCI)
Collaborator