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Clinical Trial Detail

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

Complete title: HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Clinical Trial: A Randomized, Double-Blind, Placebo-Controlled Trial

Research Study Number 9790
Principal Investigator Anna Wald, MD, MPH
Phase IV

Research Study Description

This randomized 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 27 Years to 69 Years (Adult, Senior)

Sexes Eligible for Study: All

- Age 27- 69 at diagnosis of HSIL

- Histologically confirmed diagnosis of anal or vulvar high-grade squamous intraepithelial lesion (HSIL) (anal intraepithelial neoplasia [AIN]2/3-vulvar intraepithelial neoplasia [VIN]2/3); 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, diagnosed on or after 1/1/2014

- 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 one time, >= 2 months after therapy

- Resident in the area and willing to attend up to 7 clinic visits for a 36-month period at the Virology Research Clinic (VRC)

- 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 for at least 6 months

- Ability to give informed consent

- Willingness to sign medical records release form and tissue release form

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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 (throat, 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

- 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

Other exclusion criteria may apply.

Research Study Number 9790
Contact UW Virology Research Clinic Study Line
Telephone 206/520-4340

Keywords: Anal Cancer; Cervical Cancer; Solid Tumors; Uterine Cancer; Vulvar Cancer; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Carcinoma in Situ; Carcinoma

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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