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

September 23, 2010 updated by: Tigris Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama Highlands, Dept. of OB/GYN
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • HOPE Research Institute, LLC
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucson
    • California
      • Carmichael, California, United States, 95608
        • Northern California Research Corp
      • Colton, California, United States, 92324
        • Arrowhead Regional Medical Center
      • Costa Mesa, California, United States, 92629
        • Robin Black OGNP
      • San Diego, California, United States, 92121
        • IGO Medical Group of San Diego
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • Pembroke Pines, Florida, United States, 33024
        • Global OB/GYN Centers of Florida
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research, LLC.
      • West Palm Beach, Florida, United States, 33401
        • OB/GYN Specialists of the Palm Beaches
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Research, LLC
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • East Jefferson OB/GYN
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Office of R. Garn Mabey, MD
    • New Jersey
      • Neptune, New Jersey, United States, 07754
        • Jersey Shore University Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health
      • New York, New York, United States, 10038
        • New York Downtown Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Greater Cincinnati OB/GYN, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center Dept of OB/GYN
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • LeHigh Valley Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
    • Texas
      • Austin, Texas, United States, 78737
        • Hill Country OB/GYN
      • Houston, Texas, United States, 77004
        • Planned Parenthood of Houston & Southeast Texas, Inc.
      • Plano, Texas, United States, 75093
        • 4601 Old Shepard Place; Bldg 2, Suite 201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
Drug: placebo
5 days of 28 day cycle for 2 cycles
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.
Drug: A007
5 days of 28 day cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological Response
Time Frame: baseline and 4 months
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
baseline and 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
over the course of the trial
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
over the course of the trial
Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.
Time Frame: over the course of the trial
over the course of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tigris Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 Presbyterian 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, Augusta 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, Medstar Health Research Institute
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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