HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions (NCT03051516) | Clinical Trial Compass
TerminatedPhase 4
HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
Stopped: The study was terminated early due to futility.
United States188 participantsStarted 2017-08-01
Plain-language summary
This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or come back.
Who can participate
Age range27 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion (AIN2/3 or VIN2/3) diagnosed on or after 1/1/2014; study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
* \>= 2 months since last therapy for HSIL
* No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened \>= 2 months after therapy
* Resident in the catchment area of the clinics and willing to attend up to 8 clinic visits for a 36-month period
* Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
* If human immunodeficiency virus (HIV) positive, receipt of anti-retroviral therapy continuously for at least 6 months prior to enrollment
* Ability to give informed consent
* Willingness to sign medical records release form and tissue release form
Exclusion Criteria:
* Currently pregnant
* Chemotherapy (current, within the last month, or anticipated in the next 7 months)
* Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
* Unstable medical condition (e.g., another malignancy requ…
What they're measuring
1
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients