HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Terminated; Phase 4

Conditions: High Grade Anal Canal Intraepithelial Neoplasia; High Grade Vulvar Squamous Intraepithelial Lesion

Treatments: Other: Placebo Administration; Other: Laboratory Biomarker Analysis; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03051516

R01CA213130 (U.S. NIH Grant/Contract)

RG1001522 (Other Identifier)

9790 (Other Identifier)

NCI-2017-00151 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 27 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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188 participants in 2 patient groups, including a placebo group

Arm I (recombinant human papillomavirus nonavalent vaccine)

Experimental group

Description:

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.

Treatment:

Other: Laboratory Biomarker Analysis

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Other: Questionnaire Administration

Arm II (placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Placebo Administration