Overview

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

Status:
Completed
Trial end date:
2008-06-01
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:

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.