SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Cervical Cancer, Precancerous Condition
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 3
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC at least 3,500/mm^3 Lymphocyte count at least 500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL No significant hematologic disease that is uncontrolled with standard therapy Hepatic Bilirubin no greater than 2 mg/dL Liver enzymes no greater than 2.5 times normal No significant hepatic disease that is uncontrolled with standard therapy Renal Creatinine no greater than 2 mg/dL No significant renal disease that is uncontrolled with standard therapy Cardiovascular No significant cardiovascular disease that is uncontrolled with standard therapy Pulmonary No significant respiratory disease that is uncontrolled with standard therapy No history of asthma Immunologic HIV negative No clinical evidence of immunosuppression No autoimmune disease No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study No history of a positive purified protein derivative (PPD) or Tine test Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile No uncontrolled chronic disease Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy No other underlying or unstable disease that would be exacerbated by the study treatment PRIOR CONCURRENT THERAPY: Biologic therapy No prior BCG vaccination No other concurrent vaccine therapy Chemotherapy No concurrent chemotherapy Endocrine therapy More than 30 days since prior oral or parenteral glucocorticoid steroid Radiotherapy Not specified Surgery Not specified Other More than 30 days since prior participation in another investigational study No concurrent cytotoxic therapy No other concurrent investigational agents No other concurrent investigational or commercial agents or therapies intended to treat CIN
Sites / Locations
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- New York Weill Cornell Cancer Center at Cornell University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1 month follow-up
2 month follow-up
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy