A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tigris Pharmaceuticals

Criteria

Inclusion Criteria:

• 18 years of age or older

• The patient or her authorized representative must sign and date an Ethical Review Board-approved informed consent document. All aspects of the protocol must be explained and written informed consent obtained.

• Patients must have histologic proof of CIN 2/3 disease documented within the last 12 weeks. If patient is enrolled using prior local biopsy, local slides and pathology report must be sent to the central laboratory. Patient may be enrolled into the study based on local laboratory results of CIN 2/3 and will not be discontinued if central laboratory results differ.

• Cervical swabs must test positive for high risk HPV (by Hybrid Capture 2). If the patient tests negative for high risk HPV and has proof of CIN 2/3, the patient should be retested one additional time for high-risk HPV.

• Patients must have a Hgb ≥ 9 g/dl, a peripheral WBC ≥ 3000 mm3 and platelet counts ≥100,000 mm3.

• Normal hepatic and renal functions - AST and ALT <2.5 x ULN and creatinine <1.5 x ULN, respectively.

• Females of childbearing potential must use one of the following birth control methods during the study (until performance of the LEEP at month 4): oral, implantable, injectable contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, vaginal contraceptive rings, spermacides, sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.

Exclusion Criteria:

• Patients with CIN 1 or with invasive squamous cell carcinoma (SCC).

• CIN appearing to involve the endocervix, as assessed colposcopically

• CIN not amenable to adequate colposcopic follow-up evaluations, i.e. unsatisfactory colposcopy.

• CIN 3 involving more than two cervical quadrants on colposcopy.

• Patients treated for cervical SIL within the past year.

• Patients who have had a LEEP performed in the past 12 months

• Patients with other malignancy (except non-melanoma skin) within the past 5 years.

• Patients with any chronic, active infections (including HIV) other than HPV.

• Patients with known clinically relevant immunological deficiency.

• Concurrent treatment with cytotoxic, radiation, or immuno-stimulative therapy, or with systemic corticosteroids at a dose >5 mg/d of prednisone (or its equivalent).

• Participation in another investigational medication trial concurrently or within 30 days, or prior administration of a prophylactic HPV vaccine or participation in an HPV vaccine trial. Treatment within the last 30 days with a medication that has not received regulatory approval at the time of study entry.

• Concomitant use of topical vaginal medications.

• Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

• History of allergy or hypersensitivity to cosmetics, toiletries, or other topical or dermatologic products.

• Pregnant or lactating females who are nursing and will not consent to cease nursing.

• Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

• Patients with known menstrual irregularity that is not resolved with cycling on hormonal contraception.