- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00596258
A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL) (TG-003)
A Two-Stage Phase 2 Study Of Dose-Intense 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-Hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a non-randomized, two-stage phase II study with pathological response rate as the primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 14 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 (see schedule of events in attachment TG-003.01 for visit intervals).
Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted according to the procedures and guidelines of their institution.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forente stater, 85712
- Visions Clinical Research-Tucson
-
-
California
-
Costa Mesa, California, Forente stater, 92629
- Robin Black OGNP
-
-
Florida
-
Boynton Beach, Florida, Forente stater, 33437
- Visions Clinical Research
-
-
New York
-
Bronx, New York, Forente stater, 10461
- Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health
-
New York, New York, Forente stater, 10016
- NYU School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion 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 histologic proof of CIN 2/3 disease documented within the last 12 weeks. If patient is enrolled using prior local biopsy, local slides and pathology report must be sent to the central laboratory. Patient may be enrolled into the study based on local laboratory results of CIN 2/3 and will not be discontinued if central laboratory results differ.
- Cervical swabs must test positive for high risk HPV (by Hybrid Capture 2). If the patient tests negative for high risk HPV and has proof of CIN 2/3, the patient should be retested one additional time for high-risk HPV.
- Patients must have a Hgb ≥ 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 study (until performance of the LEEP at month 4): oral, implantable, injectable contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, vaginal contraceptive rings, spermacides, sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.
Exclusion Criteria:
- Patients with CIN 1 or with invasive squamous cell carcinoma (SCC).
- CIN appearing to involve the endocervix, as assessed colposcopically
- CIN 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 who have had a LEEP performed in the past 12 months
- Patients with other malignancy (except non-melanoma skin) within the past 5 years.
- Patients with any chronic, 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 >5 mg/d of prednisone (or its equivalent).
- Participation in another investigational medication trial concurrently or within 30 days, or prior administration of a prophylactic HPV vaccine or 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.
- Patients with known menstrual irregularity that is not resolved with cycling on hormonal contraception.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: A-007
Single arm open label
|
applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine overall pathological response (complete and partial, based on independent review at month 4) of A-007 when applied topically for two 28-day cycles of 14 consec. days of treatment each to the uterine cervix of women with HSIL [CIN 2/3].
Tidsramme: Over the course of the trial
|
Over the course of the trial
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the local tolerability and systemic safety of A-007.
Tidsramme: over the course of the trial
|
over the course of the trial
|
Evaluate the effects of A-007 gel treatment on human papillomavirus (HPV) eradication.
Tidsramme: over the course of the trial
|
over the course of the trial
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Keith A Aqua, MD, Visions Clinical Research
- Hovedetterforsker: Mark H Einstein, MD, Montefiore Medical Center-Weiler Division
- Hovedetterforsker: Cynthia J Goldberg, MD, Visions Clinical Research-Tucson
- Hovedetterforsker: Robert Pfeffer, MD, Robin Black OGNP, Costa Mesa California
- Hovedetterforsker: Stephanie Blank, MD, NYU School of Medicine
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Morgan LR, Thangaraj K, LeBlanc B, Rodgers A, Wolford LT, Hooper CL, Fan D, Jursic BS. Design, synthesis, and anticancer properties of 4,4'-dihydroxybenzophenone-2,4-dinitrophenylhydrazone and analogues. J Med Chem. 2003 Oct 9;46(21):4552-63. doi: 10.1021/jm0301080.
- Morgan, LR, Hooper, CL, Rodgers, AH, LoRusso, P, Eilender, DE and Culotta, VA. 4,4'-Dihydroxybenzophenone-2,4-dinitrophenyl-hydrazone (A-007): A CD4+ T-Lymphocyte Modulator Useful in the Treatment of Advanced Cancer. Chemotherapy - accepted 2005.
- Morgan, LR, Hooper, CL, Rodgers, AH Culotta, V et al. 4,4'-Dihydroxy benzophenone -2,4-dinitrophenylhydrazone (A-007) A Modulator of CD45+ T Lymphocytes in HPV Infected Anogenital Epithelium. In: HPV Vaccines and Immune Therapy, Cambridge, United Kingdom, 2003
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Karsinom
- Neoplasmer, kjertel og epitel
- Livmor livmorhalssykdommer
- Livmorsykdommer
- Forstadier til kreft
- Neoplasmer, plateepitelceller
- Neoplasmer
- Karsinom in situ
- Cervikal intraepitelial neoplasi
- Karsinom, plateepitel
- Livmor livmorhalsdysplasi
- Plateepiteliale lesjoner i livmorhalsen
Andre studie-ID-numre
- TG-003
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. .
Kliniske studier på Cervikal intraepitelial neoplasi
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeCervical Intraepitelial Neoplasia Grad 2/3 | Høygradig cervikal intraepitelial neoplasi | Cervical plateepitelkarsinom in situ | Cervical squamous intraepitelial neoplasia 2Forente stater
-
University Hospital, GenevaFullførtCervical intra-epitelial neoplasi grad 1 eller verreSveits
-
Jonsson Comprehensive Cancer CenterMerck Sharp & Dohme LLCRekrutteringCervikal intraepitelial neoplasi | Cervical plateepitelkarsinom in situ | Cervical squamous intraepitelial neoplasia 2Forente stater
-
University of Alabama at BirminghamNational Cancer Institute (NCI)FullførtHøygradig Cervical Intraepitelial NeoplasiaForente stater
-
BioLeaders CorporationUkjentCervical Intraepitelial Neoplasia Grad 2/3Korea, Republikken
-
University of California, San FranciscoFullført
-
University of WashingtonNational Cancer Institute (NCI)FullførtLivmorhalskreft | Infeksjon av humant papillomavirus | Helsestatus ukjent | Cervical Intraepitelial Neoplasia Grad 2/3 | Stadium 0 Livmorhalskreft | Atypisk plateepitelcelle av ubestemt betydning | Lavgradig cervical plateepitel intraepitelial neoplasiForente stater
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)FullførtLivmorhalskreft | Cervical Intraepitelial Neoplasia Grad 2/3 | Stadium 0 LivmorhalskreftForente stater
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Frantz Viral TherapeuticsFullførtCervical Intraepitelial Neoplasia Grad 2/3 | Høyrisiko HPV (alle stammer)Forente stater
-
GY Highland Biotech LLCUkjentCervical Intraepitelial Neoplasia Grad 2/3Forente stater
Kliniske studier på A-007
-
DEKK-TEC, Inc.FullførtHIV-infeksjoner | Lymfoproliferative lidelser | Sarkom, KaposiForente stater
-
Apollo Therapeutics LtdAvsluttetAdult Debut Still's DiseaseForente stater, Belgia, Polen, Ukraina
-
Dr. August Wolff GmbH & Co. KG ArzneimittelParexelFullførtDermatitt, atopiskTyskland
-
Oblato, Inc.RekrutteringAstrocytom | Glioblastoma Multiforme | Oligodendrogliom | Gliom av høy kvalitetForente stater
-
Qilu Pharmaceutical Co., Ltd.Ukjent
-
Nanjing Leads Biolabs Co.,LtdRekrutteringAvansert solid svulstKina
-
Recognify Life SciencesFullførtSchizofreni | Kognitiv sviktForente stater
-
Suzhou Yabao Pharmaceutical R&D Co., Ltd.Suspendert
-
Oblato, Inc.Aktiv, ikke rekrutterendeTilbakevendende ondartet gliomForente stater
-
Intra-Cellular Therapies, Inc.FullførtSchizofreniForente stater