SGN-00101 (HspE7) Immunotherapy Of CIN III
HspE7
Urogenital Diseases+12
+ Genital Diseases
+ Uterine Cervical Diseases
Prevention Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
New York Weill Cornell Cancer Center at Cornell University
New York, United StatesOpen New York Weill Cornell Cancer Center at Cornell University in Google MapsAlbert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, United States