Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
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
Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of
Arm II: Patients receive standard care.
At week 15, all patients undergo large loop excision of the transformation zone under
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|