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

This study has been completed.
Sponsor:
Information provided by:
Tigris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00285207
First received: January 30, 2006
Last updated: September 23, 2010
Last verified: September 2010

January 30, 2006
September 23, 2010
January 2006
April 2008   (final data collection date for primary outcome measure)
Pathological Response [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
To determine the pathological response (based on independent pathology review at month 4) of A-007 as compared to placebo, to the uterine cervix of women with HSIL [CIN 2/3]
Complete list of historical versions of study NCT00285207 on ClinicalTrials.gov Archive Site
  • Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0. [ Time Frame: over the course of the trial ] [ Designated as safety issue: No ]
  • Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection. [ Time Frame: over the course of the trial ] [ Designated as safety issue: No ]
  • Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection. [ Time Frame: over the course of the trial ] [ Designated as safety issue: No ]
  • 1) Local tolerability and systemic safety of A-007 will be assessed by way of CTCAE 3.0
  • 2) Eradication of human papilloma virus (HPV) will be assessed by way of cervical cytology and swab collection.
  • 3)Immunologic parameters B/T cells will be assessed by B/T cell profile collection.
Not Provided
Not Provided
 
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia
  • Drug: placebo
    5 days of 28 day cycle for 2 cycles
    Other Name: placebo
  • Drug: A007
    5 days of 28 day cycle
    Other Name: A007
  • Placebo Comparator: Placebo
    Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
    Intervention: Drug: placebo
  • Experimental: A007
    0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
    Intervention: Drug: A007

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
June 2008
April 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00285207
TG-001
No
Chief Medical Officer, Tigris
Tigris Pharmaceuticals
Not Provided
Principal Investigator: John A Burigo, MD OB/GYN Specialists of the Palm Beaches
Principal Investigator: Ramon Cestero, MD Arrowhead Regional Medical Center
Principal Investigator: Paul M Fine, MD Planned Parenthood of Houston & Southeast Texas, Inc.
Principal Investigator: Keith A Aqua, MD Visions Clinical Research
Principal Investigator: Steven C Blank, MD Mount Vernon Clinical Research, LLC
Principal Investigator: Douglas G Young, MD Northern California Research Corp
Principal Investigator: Allan T Sawyer, MD Hope Research Institute, LLC
Principal Investigator: Mark H Einstein, MD Montefiore Medical Center-Weiler Division
Principal Investigator: Robert M Spitz, MD Coastal Connecticut Research, LLC
Principal Investigator: Thomas A deHoop, MD Greater Cincinnati OB/GYN, Inc.
Principal Investigator: Lance R Bruck, MD Jacobi Medical Center
Principal Investigator: Warner K Huh, MD University of Alabama Highlands, Dept. of OB/GYN
Principal Investigator: Giuseppe Del Priore, MD New York Downtown Hospital
Principal Investigator: Michael A Gold, MD University of Oklahoma Health Sciences Center Dept of OB/GYN
Principal Investigator: Richard S Guido, MD Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services
Principal Investigator: Philip E Young, MD IGO Medical Group of San Diego
Principal Investigator: Daron G. Ferris, MD Georgia Regents University
Principal Investigator: Cynthia J Goldberg, MD Visions Clinical Research-Tucson
Principal Investigator: Ana Eduardo, MD Hill Country OB/GYN
Principal Investigator: Phyllis Gee, MD OB/GYN
Principal Investigator: Robert Pfeffer, MD Robin Black OGNP, Costa Mesa California
Principal Investigator: Jonathan A Cosin, MD Washington Hospital Center
Principal Investigator: James A Williams, MD South Carolina Oncology Associates
Principal Investigator: Vincent A Culotta, Jr, MD East Jefferson OB/GYN
Principal Investigator: G. Michael Swor, MD Physician Care Clinical Research, LLC.
Principal Investigator: Garn R Mabey, MD Office of R. Garn Mabey, MD
Principal Investigator: Martin Martino, MD Lehigh Valley Hospital
Principal Investigator: Robert Klein, MD Global OB/GYN Centers of Florida
Principal Investigator: William J Mann, MD Jersey Shore University Medical Center
Tigris Pharmaceuticals
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP