Brief Title
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Official Title
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete histologic regression of all CIN 3 lesions
Condition
Cervical Cancer
Intervention
HspE7
Study Arms / Comparison Groups
Arm I (HspE7)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
84
Start Date
June 2004
Primary Completion Date
January 2007
Eligibility Criteria
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
Gender
Female
Ages
17 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Cornelia Trimble, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00054041
Organization ID
NCI-2012-02513
Secondary IDs
GOG-0197
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Cornelia Trimble, Principal Investigator, Gynecologic Oncology Group
Verification Date
January 2013