on-randomised phase II trial of Sequential Therapy of Imiquimod followed by Vaccination with TA CIN for High Grade VI
- Conditions
- VIN3
- Registration Number
- EUCTR2005-001824-35-GB
- Lead Sponsor
- niversity of Manchester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
•Female
•Aged 18-70
•Non-child bearing or using effective contraception
•Patients with VIN3 or AIN3, histologically confirmed by biopsy within the previous 3 months
•Given written informed consent
•Patients must have at least one lesion of sufficient size to allow biopsies to be taken on 3 occasions and for disease evaluation to be performed. (It is estimated that a lesion of approximately 1 cm diameter would be sufficient.)
Are the trial subjects under 18? no
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
•Any patient who has received active treatment for VIN3 or AIN3 in the previous 4 weeks prior to enrolment.
•Any patient with VAIN3 requiring treatment
•Any patient who has received an HPV vaccine in the past
•Known immunodeficiency, defined as:
•Active eczema in the last 12 months
•Any patient who is pregnant, planning pregnancy, or breast feeding
•Any patient receiving immunosuppressive therapy
•Any patient with clinically significant abnormal serum biochemistry, haematology or urinanalysis
•Any patient with evidence of an ongoing infection
•History of severe allergy including eczema or other exfoliative skin disorder or active skin diseases such as psoriasis, lichen planus or sepsis among patients or among close social, sexual or domestic contacts
•History of severe adverse reaction to any vaccine
•Receipt of blood or blood products in the last 3 months
•Women whose last cervical smear was abnormal. If their last smear was more than 3 years ago, it must be repeated at screening
•Any patient who either has ano-genital carcinoma or who, in the investigator’s opinion, is at high risk of developing ano-genital carcinoma over the next 6 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the objective response of VIN lesions to treatment with imiquimod followed by vaccination with TA-CIN;Primary end point(s): Lesion size at 12 months post treatment.;<br> Secondary Objective: To evaluate the safety, toxicity and tolerability of the combination of imiquimod and TA-CIN vaccination in VIN (vulval and peri-anal)<br><br> To evaluate symptom responses as documented by patients in a daily diary and as reported at clinic visits.<br><br> To characterise and quantify the immune responses in VIN lesions and peripheral blood of patients treated with imiquimod and TA-CIN.<br>
- Secondary Outcome Measures
Name Time Method