SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

Study Overview
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Brief Summary
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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: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Detailed Description
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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.

Official Title
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Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III

Conditions
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Precancerous Condition

Intervention / Treatment
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* Biological: HspE7


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HspE7|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection