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
Full Title of Study: “Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3″
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2007
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.
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.
- Biological: HspE7
- Given subcutaneously
- Procedure: therapeutic conventional surgery
- Undergo large loop excision
- Other: laboratory biomarker analysis
- Correlative studies
Arms, Groups and Cohorts
- Experimental: Arm I (HspE7)
- 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.
- Experimental: Arm II (control)
- Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Clinical Trial Outcome Measures
- Complete histologic regression of all CIN 3 lesions
- Time Frame: Up to 3 years
- 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.
- Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
- Time Frame: Up to 3 years
Participating in This Clinical Trial
- 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
Gender Eligibility: Female
Minimum Age: 17 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Cornelia Trimble, Principal Investigator, Gynecologic Oncology Group
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