SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
Precancerous Condition
About this trial
This is an interventional treatment trial for Precancerous Condition focused on measuring cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital