Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
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
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.
Inclusion Criteria:
Histologically confirmed grade III cervical intraepithelial neoplasia
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