SGN-00101 (HspE7) Immunotherapy Of CIN III

Fecha de inicio: 1 de marzo de 2004

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