Status:
COMPLETED
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Lead Sponsor:
Tigris Pharmaceuticals
Conditions:
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00285207
Start Date
January 1 2006
End Date
June 1 2008
Last Update
October 11 2010
Active Locations (29)
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1
University of Alabama Highlands, Dept. of OB/GYN
Birmingham, Alabama, United States, 35205
2
Hope Research Institute, LLC
Phoenix, Arizona, United States, 85032
3
Visions Clinical Research-Tucson
Tucson, Arizona, United States, 85712
4
Northern California Research Corp
Carmichael, California, United States, 95608