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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cervical Intraepithelial Neoplasia, Uterine Cervical Dysplasia

In brief

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.

Key facts

Study ID

NCT00285207

Run by

Tigris Pharmaceuticals

People needed

147

Starts

2006-01-01

Expected to finish

2008-06-01

Last updated by the study team

2010-10-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama Highlands, Dept. of OB/GYN — Birmingham, Alabama, United States
• Hope Research Institute, LLC — Phoenix, Arizona, United States
• Visions Clinical Research-Tucson — Tucson, Arizona, United States
• Northern California Research Corp — Carmichael, California, United States
• Arrowhead Regional Medical Center — Colton, California, United States
• Robin Black OGNP — Costa Mesa, California, United States
• IGO Medical Group of San Diego — San Diego, California, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Global OB/GYN Centers of Florida — Pembroke Pines, Florida, United States
• Physician Care Clinical Research, LLC. — Sarasota, Florida, United States
• OB/GYN Specialists of the Palm Beaches — West Palm Beach, Florida, United States
• Mount Vernon Clinical Research, LLC — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• East Jefferson OB/GYN — Metairie, Louisiana, United States
• Office of R. Garn Mabey, MD — Las Vegas, Nevada, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• New York Downtown Hospital — New York, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health — The Bronx, New York, United States
• Greater Cincinnati OB/GYN, Inc. — Cincinnati, Ohio, United States
• University of Oklahoma Health Sciences Center Dept of OB/GYN — Oklahoma City, Oklahoma, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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