Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Condition: Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell
Intervention: placebo; A007
Intervention description: 5 days of 28 day cycle for 2 cycles; 5 days of 28 day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cervical Intraepithelial Neoplasia (CIN); High-grade Cervical Intraepithelial Neoplasia; High-grade Squamous Intraepithelial Lesions (HSIL); Human Papilloma Virus (HPV); High-Grade Cervical Intraepithelial Lesions (CIN 2/3)

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients may be enrolled in the study only if they meet all of the following 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 histological proof of HSIL (CIN 2/3) disease documented.

          -  Cervical swabs must test positive for HPV (by Hybrid Capture 2).

          -  Patients must have a Hb ≥ 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 treatment period and 2 weeks thereafter: oral, implantable, injectable
             contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, spermicides,
             sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.

        Exclusion Criteria:

        Patients will be excluded from the study for any of the following preexisting reasons:

          -  Patients with LSIL (CIN 1) or invasive squamous cell carcinoma (SCC).

          -  SIL (CIN) involving the endocervix as determined by endocervical curettage, or
             otherwise 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 with other malignancy (except for non-melanoma skin) within the past 5 years.

          -  Patients with any 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 of > 5 mg/d of prednisone (or its equivalent).

          -  Participation in another investigational medication trial concurrently or within 30
             days, or prior 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.