Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Study Overview
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Brief Summary
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Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

Detailed Description
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PRIMARY OBJECTIVES: I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine change in lesion size in these patients after treatment with this drug. II. Compare histologic response before and after treatment with this drug in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. Arm II: Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Official Title
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Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Conditions
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Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection

Intervention / Treatment
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* Biological: HspE7
* Procedure: therapeutic conventional surgery
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed grade III cervical intraepithelial neoplasia Confirmed by biopsy or colposcopy Positive for human papilloma virus 16 No endocervical glandular dysplasia No adenocarcinoma in situ Performance status - GOG 0-2 No life-threatening or serious hematological disorder No life-threatening or serious hepatic disorder No life-threatening or serious renal disorder No life-threatening or serious cardiac disorder No life-threatening or serious respiratory disorder HIV negative Must be immunocompetent No history of autoimmune disease No life-threatening or serious immunological disorder No prior or concurrent severe allergic disease No concurrent human papilloma viral infection other than type 16 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No life-threatening or serious gastrointestinal disorder No life-threatening or serious endocrine disorder No invasive malignancy within the past 5 years except nonmelanoma skin cancer No concurrent chronic or systemic steroids No prior organ transplantation No prior cancer therapy that would preclude study therapy

Ages Eligible for Study
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Minimum Age: 17 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (HspE7)<br>Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. | Biological: HspE7<br>* Given subcutaneously<br>* Other names: SGN-00101;Procedure: therapeutic conventional surgery<br>* Undergo large loop excision<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Experimental: Arm II (control)<br>Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. | Procedure: therapeutic conventional surgery<br>* Undergo large loop excision<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete histologic regression of all CIN 3 lesions | Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm. | Up to 3 years | 
| Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0 |  | Up to 3 years |