Status:
COMPLETED
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief 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 cervica...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00075569
Start Date
March 1 2004
End Date
August 1 2005
Last Update
May 21 2018
Active Locations (2)
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1
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
2
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States, 10461