A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5x10E7pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectio
- Conditions
- High grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infectionMedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia IIMedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia III
- Registration Number
- EUCTR2008-006946-24-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
1. Are greater than or equal to 18 years old
2. Have provided written informed consent
3. Have a negative serum pregnancy test at screening
4. Use effective contraception for the first 6 months of the study; 2 methods of contraception, one of which must be barrier, should be used; abstinence is acceptable
5. Have a pap smear test documenting, ASCUS, ASC-H, LSIL or HSIL within 3 months of screening
6. Have a diagnosis within 2 months prior to the first dose of RO5217790 of CIN 2/3 confirmed by colposcopy-directed punch biopsy; patients must have at least 1 quadrant of residual CIN2/3 disease remaining after biopsy. Entry to the trial will be allowed based on the local assessment of this criterion; however, CIN 2/3 diagnosis will have to be confirmed by the central pathologist for the purposes of analyzing the study
7. Have satisfactory colposcopy, i.e. the entire aceto-white or disease area as well as the entire squamocolumnar junction visualized by colposcopy
8. Have detection at screening of a single or multiple HR-HPV infection by analysis of liquid based cytology (LBC) material on the Roche Linear Array assay consistent with any of the trial strata as specified in section 3.1
9. Have no clinically significant out of range hematological, renal, or hepatic laboratory tests. Specifically, patients should have white blood cell count >3x1'000'000'000/L, hemoglobin>10g/dL, platelet count >150'000/µL; ALT<2.0xULN, AST <2xULN (upper limit of normal) and serum creatinine <2mg/dL
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
1. Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
2. Have had any previous excisional or ablative surgical treatment for CIN
3. Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
4. Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
5. Have any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the transformation zone and surveillance of CIN. If an ECC is performed, and the endocervical curettings reveal CIN, patients are eligible as long as the endocervical lesion is directly extending from the primary lesion and is colposcopically visible in its entirety
6. Have previously received a prophylactic HPV vaccine
7. Have a serious, concomitant disorder, including active systemic infection requiring treatment
8. Have a prior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma), unless the history of skin cancer is at the site of study treatment administration
9. Have a proven or suspected immunosuppressive disorder or autoimmune disease
10. Have any significant cardiac, hepatic or renal disease
11. Are breast-feeding
12.Have a known allergy to eggs
13. Have previous (within 4 weeks prior to Day 1) concomitant long term treatment with systemic steroids, immunosuppressive/immunomodulating drugs (e.g. cyclosporine, corticosteroids). Steroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible
14. Have received any vaccination within 30 days of study treatment
15. Have active significant viral infections including HIV, HCV, HBV, CMV, and EBV within 30 days of receiving study treatment. Mild viral infections such as HSV-1 or common cold are not excluded
16. Have participated in another experimental protocol/use of investigational drug during the prior 6 months
17. Are unable to comply with the protocol requirements
18. Have any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method