Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Phase 2

Withdrawn

Conditions: precancerous lesion of the vulvae
Vulvar Intraepithelial neoplasia
10047438
10038588
10040785

Registration Number: NL-OMON33950

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 98

Inclusion Criteria

- Histological proven usual type VIN, without invasion
- Previous treatment with imiquimod for 12-16 weeks with a partial response to
imiquimod treatment defined as a reduction in lesion size of 26%-99%
- The patient is willing to use a medically acceptable method of contraception throughout the study
- Age 18 and above

Exclusion Criteria

- (Micro-)invasive carcinoma
- Pregnancy and/or breastfeeding
- Past history of vulvar cancer
- Differentiated (non HPV-related) VIN
- Other treatment of VIN or anogenital warts within 1 month of start trial
- Hypersensitivity to any components of the vaccine or cream formulation
- History of psoriasis or other inflammatory dermatosis of the vulva
- Immunodeficiency (e.g. HIV, corticosteroid use)
- Insufficient understanding of the Dutch Language
- Partial responders who are disease-free at study-entry due to other treatment of VIN

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical response to the treatment in VIN lesions after the end of imiquimod<br /><br>treatment and the last vaccination, measured by 1) reduction in lesion size, 2)<br /><br>histological regression of usual type VIN to normal vulvar tissue and 3)<br /><br>relieve of symptoms. Other main study parameters are absence of HPV DNA in the<br /><br>original VIN lesions after treatment, normalization of immunocompetent cell<br /><br>counts and production of cytokines in peripheral blood and by Peripheral Blood<br /><br>Mononuclear Cells (PBMCs). </p><br>

Secondary Outcome Measures