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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

23. september 2010 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

147

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Legemiddel: placebo
5 days of 28 day cycle for 2 cycles
Eksperimentell: A007
0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.
Legemiddel: A007
5 days of 28 day cycle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tigris Pharmaceuticals

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2006

Primær fullføring (Faktiske)

1. april 2008

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

30. januar 2006

Først innsendt som oppfylte QC-kriteriene

30. januar 2006

Først lagt ut (Anslag)

1. februar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. oktober 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2010

Sist bekreftet

1. september 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TG-001

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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