NCT00060099

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia. PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
Last Updated

November 6, 2013

Status Verified

March 1, 2005

First QC Date

May 6, 2003

Last Update Submit

November 5, 2013

Conditions

Precancerous Condition

Keywords

cervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3human papilloma virus infection

Interventions

HspE7BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed grade II or III cervical intraepithelial neoplasia * Confirmed by colposcopy-directed punch biopsy * Accessible, definable, and entirely visible cervical lesions persisting after biopsy * Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy * Positive for human papilloma virus 16 * CD4+ counts normal PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0 Life expectancy * Not specified Hematopoietic * No coagulation disorder that requires medical intervention Hepatic * Hepatitis B core antigen negative * Hepatitis C antibody negative Renal * Not specified Cardiovascular * No cardiovascular disorder that requires medical intervention Pulmonary * No respiratory disorder that requires medical intervention Immunologic * HIV negative * Not immunologically compromised * No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen * No immunological disorders including any of the following: * Lupus * Diabetes * Multiple sclerosis * Myasthenia gravis * No active systemic infections that require medical intervention Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to undergo a loop electrosurgical excision procedure * No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance * No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No other concurrent gene therapy * No concurrent biologic therapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 30 days since prior systemic steroid therapy Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational drugs * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Precancerous ConditionsUterine Cervical DysplasiaPapillomavirus Infections

Condition Hierarchy (Ancestors)

NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristin A. Keefe, MD

    Dana-Farber/Brigham and Women's Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

May 1, 2003

Last Updated

November 6, 2013

Record last verified: 2005-03

Locations

US(1)