sgn-00101 immunotherapy in treating patients with grade iii cervical intraepithelial neoplasia

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. sgn-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia. purpose: this phase ii trial is studying how well sgn-00101 immunotherapy works in preventing cervical cancer in patients with grade iii cervical intraepithelial neoplasia.

objectives: primary * determine the rate of regression at 4-7 months in patients with grade iii cervical intraepithelial neoplasia (cin iii) treated with sgn-00101 immunotherapy. * compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine. * determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients. secondary * determine induction of cell-mediated immune responses against human papillomavirus (hpv) e7 peptides before and after treatment in patients immunized with this vaccine * correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine. * correlate seropositivity of hpv-16 virus-like particles (vlp16) with vaccine-induced regression of cin iii in patients immunized with this vaccine. * determine the efficacy of this vaccine in patients whose cin iii is associated with hpv-16 infection vs other hpv types. outline: this is a multicenter study. patients are assigned to 1 of 2 treatment groups. all patients receive sgn-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity. * group 1: four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (leep) or core biopsy. * group 2: six months after the first vaccination, patients undergo therapeutic and diagnostic leep or core biopsy. patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination. projected accrual: a total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.

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

Keywords: cervical cancer cervical intraepithelial neoplasia grade 3