Clinical trial NCT03051516: HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
Official title: HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: High Grade Anal Canal Intraepithelial Neoplasia
High Grade Vulvar Squamous Intraepithelial Lesion
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-13
Enrollment: 188
Sex: ALL
Minimum age (years): 27
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, 2 months, and 6 months.

ARM II: Patients receive placebo IM at baseline, 2 months, and 6 months.

After completion of study treatment, patients are followed up at months 7, 12, 18, 24, 36, and 42.

Eligibility criteria: 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 requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)
* Prior HPV vaccination
* Known allergy or intolerance to lidocaine
* Currently participating in an interventional research study related to HPV, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT02135419)
* Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study

Primary outcomes:
measure: Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
timeFrame: Up to month 36
Secondary outcomes:
measure: Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)
timeFrame: Up to month 36
measure: Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
timeFrame: Up to month 36
measure: HPV Antibody Level
timeFrame: Up to month 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Cancer Center
state: Alabama
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Anna Wald
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stankiewicz Karita HC, Hauge K, Magaret A, Mao C, Schouten J, Grieco V, Xi LF, Galloway DA, Madeleine MM, Wald A. Effect of Human Papillomavirus Vaccine to Interrupt Recurrence of Vulvar and Anal Neoplasia (VIVA): A Trial Protocol. JAMA Netw Open. 2019 Apr 5;2(4):e190819. doi: 10.1001/jamanetworkopen.2019.0819.