Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

23. september 2010 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

147

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
Medicin: placebo
5 days of 28 day cycle for 2 cycles
Eksperimentel: A007
0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
Medicin: A007
5 days of 28 day cycle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological Response
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: over the course of the trial
over the course of the trial

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tigris Pharmaceuticals

Efterforskere

  • Ledende efterforsker: John A Burigo, MD, OB/GYN Specialists of the Palm Beaches
  • Ledende efterforsker: Ramon Cestero, MD, Arrowhead Regional Medical Center
  • Ledende efterforsker: Paul M Fine, MD, Planned Parenthood of Houston & Southeast Texas, Inc.
  • Ledende efterforsker: Keith A Aqua, MD, Visions Clinical Research
  • Ledende efterforsker: Steven C Blank, MD, Mount Vernon Clinical Research, LLC
  • Ledende efterforsker: Douglas G Young, MD, Northern California Research Corp
  • Ledende efterforsker: Allan T Sawyer, MD, HOPE Research Institute, LLC
  • Ledende efterforsker: Mark H Einstein, MD, Montefiore Medical Center-Weiler Division
  • Ledende efterforsker: Robert M Spitz, MD, Coastal Connecticut Research, LLC
  • Ledende efterforsker: Thomas A deHoop, MD, Greater Cincinnati OB/GYN, Inc.
  • Ledende efterforsker: Lance R Bruck, MD, Jacobi Medical Center
  • Ledende efterforsker: Warner K Huh, MD, University of Alabama Highlands, Dept. of OB/GYN
  • Ledende efterforsker: Giuseppe Del Priore, MD, New York Presbyterian Hospital
  • Ledende efterforsker: Michael A Gold, MD, University of Oklahoma Health Sciences Center Dept of OB/GYN
  • Ledende efterforsker: Richard S Guido, MD, Magee-Womens Hospital, Dept of OB/GYN & Reproductive Services
  • Ledende efterforsker: Philip E Young, MD, IGO Medical Group of San Diego
  • Ledende efterforsker: Daron G. Ferris, MD, Augusta University
  • Ledende efterforsker: Cynthia J Goldberg, MD, Visions Clinical Research-Tucson
  • Ledende efterforsker: Ana Eduardo, MD, Hill Country OB/GYN
  • Ledende efterforsker: Phyllis Gee, MD, OB/GYN
  • Ledende efterforsker: Robert Pfeffer, MD, Robin Black OGNP, Costa Mesa California
  • Ledende efterforsker: Jonathan A Cosin, MD, Medstar Health Research Institute
  • Ledende efterforsker: James A Williams, MD, South Carolina Oncology Associates
  • Ledende efterforsker: Vincent A Culotta, Jr, MD, East Jefferson OB/GYN
  • Ledende efterforsker: G. Michael Swor, MD, Physician Care Clinical Research, LLC.
  • Ledende efterforsker: Garn R Mabey, MD, Office of R. Garn Mabey, MD
  • Ledende efterforsker: Martin Martino, MD, LeHigh Valley Hospital
  • Ledende efterforsker: Robert Klein, MD, Global OB/GYN Centers of Florida
  • Ledende efterforsker: William J Mann, MD, Jersey Shore University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

30. januar 2006

Først indsendt, der opfyldte QC-kriterier

30. januar 2006

Først opslået (Skøn)

1. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. oktober 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2010

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TG-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner