Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

Brief Title

Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Trial of the Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

Brief 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.
    

Detailed Description

      This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a
      1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy
      confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat
      themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply
      gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will return to
      clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Pathological Response

Secondary Outcome

 Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.

Condition

Cervical Intraepithelial Neoplasia

Intervention

placebo

Study Arms / Comparison Groups

 Placebo

Description:  Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

147

Start Date

January 2006

Completion Date

June 2008

Primary Completion Date

April 2008

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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John A Burigo, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00285207

Organization ID

TG-001

Study Sponsor

Tigris Pharmaceuticals

Study Sponsor

John A Burigo, MD, Principal Investigator, OB/GYN Specialists of the Palm Beaches

Verification Date

September 2010