Overview

Topical or Ablative Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Squamous Intraepithelial Lesions

Status:
Active, not recruiting
Trial end date:
2027-06-30
Target enrollment:
0
Participant gender:
All
Summary
This randomized phase III trial compares topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI)
The Emmes Company, LLC
The EMMES Corporation
University of Arkansas
University of California, San Francisco
Treatments:
Fluorouracil
Imiquimod
Criteria
Inclusion Criteria:

- HIV-1 infection, as documented by any federally approved, licensed HIV test performed
in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit,
and confirmed by western blot or other approved test); alternatively, this
documentation may include a record that another physician has documented that the
participant has HIV infection based on prior ELISA and western blot, or other approved
diagnostic tests; an approved antibody test will be used to confirm diagnosis; if the
physician is treating a patient with combination antiretroviral therapy (cART) with a
history of HIV positivity based on an approved antibody test then repeat antibody
confirmation is not necessary

- No history of treatment or removal of HSIL

- No history of anal cancer or signs of anal cancer at baseline, and no history of
penile, vulvar, vaginal or cervical cancer

- Biopsy-proven HSIL at baseline

- At least one focus of HSIL must be identified that is not within a condyloma that may
be treated after enrollment into the study

- For females, cervical cytology (if having a cervix) and gynecologic evaluation
including vulvar examination within 12 months prior to enrollment

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

- Life expectancy of greater than 5 years

- Absolute neutrophil count: >= 750/mm^3

- Platelets: >= 75,000/mm^3

- Hemoglobin >= 9.0 g/dL

- Women of childbearing potential must have a negative urine pregnancy test within 7
days of initiating study treatment if they have been randomized to the treatment arm;
all women of childbearing potential must agree to use a reliable birth control method
(oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or permanent
sterilization, etc., or another acceptable method as determined by the investigator)
during the entire period of the trial (5 years), and must not intend to become
pregnant during study participation and for 3 months after treatment is discontinued;
all participants must be willing to comply with an acceptable birth control regimen as
determined by the Investigator

- Men randomized to the treatment arm should not father a baby while in this study; men
who could father a child should use at least two forms of birth control for 3 months
after stopping all study treatment

- Ability to understand and the willingness to sign a written informed consent document

- Participant is willing to be randomized and able to comply with the protocol

- Clinician is comfortable with either following patient for up to 5 years without
therapy or treating patient for up to 5 years

Exclusion Criteria:

- Inability to provide informed consent

- Patients who are receiving any other immunomodulatory investigational agents within
the 4 weeks before randomization enrollment, other than investigational antiretroviral
agents for HIV

- History of anal cancer, penile, vulvar, vaginal or cervical cancer

- History of prior treatment or removal of anal HSIL

- Participant has symptoms related to HSIL and would benefit more from immediate
treatment than from entry into the study and potential for randomization to active
monitoring arm

- Current systemic chemotherapy or radiation therapy that potentially causes bone marrow
suppression that would preclude safe treatment of HSIL

- History of HPV vaccination, or intention to receive an HPV vaccine during study
participation

- Prior pelvic radiation therapy that would preclude radiation therapy if anal cancer
develops

- Warts so extensive that they preclude the clinician from determining the extent and
location of HSIL

- Participant plans to relocate away from the study site during study participation