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Home > "S" Clinical Trials Conditions > SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia  SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
For Condition: Cervical Cancer
Status: Recruiting
Sponsor(s): Cornell University Medical College , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of SGN-00101 immunotherapy in preventing cervical cancer in patients who have grade III cervical intraepithelial neoplasia.
Details: OBJECTIVES: Primary - Determine the rate of regression at 4-6 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy. - Compare the rate of regression at 4-6 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 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. Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy. Patients are followed at 1 year after the first vaccination. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkEinstein, , Albert Einstein Cancer Research Center
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Thomas Caputo 212-746-3179
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Gary Goldberg 718-430-2302
Additional Information:
Study ID Numbers: CDR0000347077; NYWCCC-0309225,NCI-5850
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075569
Other Cervical Cancer Studies:
1. Carotenoid Rich Diet in Treating Cervical Dysplasia
2. Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia
3. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
4. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
5. Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Related Studies:
Other Cervical Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
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