Vulval Intraepithelial Neoplasia grade 3 (VIN 3) MedDRA version: 14.0 Level: LLT Classification code 10057313 Term: Vulval intraepithelial neoplasia grade III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Aldara 5% cream
Pharmaceutical Form: Cream
Trade Name: Vistide
Pharmaceutical Form: Gel
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female =16 years 2. Biopsy proven VIN 3 (including visible peri-anal disease not extending into the anal canal), biopsy to have been taken within the last three months 3. At least one lesion that can be accurately measured (using RECIST criteria) in at least one dimension with longest diameter = 20mm OR in two perpendicular dimensions that when multiplied together give a surface area of greater than 120mm squared 4. Using a reliable method of contraception (excluding condoms) if sexually active 5 Written informed consent to participate in trial. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any patient with impaired renal function (defined as serum creatinine> 133 µmol/l or > 1.5 mg/dl) 2. Any patient with current anogenital carcinoma or any patient who, in the PIs opinion, is at a high risk of developing invasive disease (patients in whom invasive disease or microinvasive disease is suspected should have adequate biopsies to exclude this prior to entry) 3. Pregnant, breast feeding or trying to conceive 4. Active treatment for VIN within the previous four weeks 5. Known allergy to either of the topical treatments or any components in either cream 6. Unable to comply with protocol treatment 7. Previous failure of imiquimod or cidofovir following treatment three times a week for a minimum of 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether there is evidence that either (or both) of the topical treatments are active, safe and feasible to use, and would therefore warrant further investigation in a phase III setting.;Secondary Objective: ;Primary end point(s): The primary outcome measure is histologically confirmed complete response (clear of lesion) by 30 weeks. The assessment of response will consist of the use of RECIST criteria and a histological confirmation from the site of the lesion. ;Timepoint(s) of evaluation of this end point: 30 weeks after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Toxicities 2.Concordance 3.HPV presence, HPV type, HPV integration status 4.Recurrence rate at two years (in complete responders only);Timepoint(s) of evaluation of this end point: 1. Toxicities collected throughout study 2. Concorance monitored thoughout the study 3. Evaluated at the end of the study when all translational samples have been collected 4. Approximately two years after the last randomised patient to show a complete response | — |
Countries
United Kingdom
Outcome results
None listed