Clinical trial NCT01022346: A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical intraepithelial neoplasia
RO5217790
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.


Eligibility criteria: Inclusion Criteria:

* 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
* Have satisfactory colposcopy, i.e. the entire acetowhite or disease area as well as the entire squamocolumnar junction visualized by colposcopy
* 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 study protocol

Exclusion Criteria:

* Have colposcopically visible CIN2/3 disease extending over more than 2 quadrants
* 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 endocervical curettage (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
* Have vulvar (VIN) or vaginal (VAIN) intraepithelial neoplasia
* Have atypical endometrial or glandular cells or evidence of carcinoma on biopsy
* Have a serious, concomitant disorder, including active systemic infection requiring treatment
* 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
* Have a proven or suspected immunosuppressive disorder or autoimmune disease
* Have any significant cardiac, hepatic or renal disease
* Have active viral infections including human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), cytomegalovirus (CMV), and Epstein barr virus (EBV) within 30 days of receiving study treatment. Mild viral infections such as Herpes Simplex Virus 1 (HSV-1) or common cold are not excluded

Primary outcomes:
measure: Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
timeFrame: Months 6
measure: Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision
timeFrame: Month 6
measure: Percentage of participants with viral clearance based on Roche Linear assay results
timeFrame: Months 3 and 6
measure: Percentage of participants with immunologic response to HPV antigens
timeFrame: Day 1 (predose), Days 8, 15, and 29, Months 3 and 6
measure: Percentage of Participants with at least one Adverse Events (AEs)
timeFrame: Up to Month 30
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Colton
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marrero
country: United States
state: Louisiana
city: Framingham
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Brightwaters
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New Bern
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Englewood
country: United States
state: Ohio
city: Gallipolis
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: West Reading
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Antwerpen
country: Belgium
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Tienen
country: Belgium
city: Hus
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Bordeaux
country: France
city: Dijon
country: France
city: Nantes
country: France
city: Paris
country: France
city: Reims
country: France
city: Strasbourg
country: France
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: