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SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia Clinical research trials and SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia. SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia  SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
For Condition: Cervical Cancer
Status: Recruiting
Sponsor(s): Brigham and Women's Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia . PURPOSE: Randomizedphase II trial to study the effectiveness of SGN-00101 in preventing cervical cancer in patients who have cervical intraepithelial neoplasia and human papillomavirus.
Details: OBJECTIVES: - Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia. - Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug. OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision. PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) 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 II or III cervical intraepithelial neoplasia - Confirmed by colposcopy-directed punch biopsy - Accessible, definable, and entirely visible cervical lesions persisting after biopsy - Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy - Positive for human papilloma virus 16 - CD4+ counts normal PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0 Life expectancy - Not specified Hematopoietic - No coagulation disorder that requires medical intervention Hepatic - Hepatitis B core antigen negative - Hepatitis C antibody negative Renal - Not specified Cardiovascular - No cardiovascular disorder that requires medical intervention Pulmonary - No respiratory disorder that requires medical intervention Immunologic - HIV negative - Not immunologically compromised - No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen - No immunological disorders including any of the following: - Lupus - Diabetes - Multiple sclerosis - Myasthenia gravis - No active systemic infections that require medical intervention Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing to undergo a loop electrosurgical excision procedure - No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance - No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy - No other concurrent gene therapy - No concurrent biologic therapy Chemotherapy - No concurrent chemotherapy Endocrine therapy - More than 30 days since prior systemic steroid therapy Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 30 days since prior investigational drugs - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KristinKeefe, Study Chair, Brigham and Women's Hospital
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Kristin Keefe 617-732-5500
Additional Information:
Study ID Numbers: CDR0000299462; BWH-000-P-CONS01,NCI-3074
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060099
Other Cervical Cancer Studies:
1. SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
2. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
3. Gene Therapy in Treating Patients With Cancer
4. Epoetin beta in Treating Anemia in Patients With Cervical Cancer
5. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Related Studies:
Other Cervical Cancer Clinical Trials
Other Massachusetts Clinical Trials
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SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
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