Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
17 Years
N/A
Female
Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection
Trial Information
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
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
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete histologic regression of all CIN 3 lesions
Outcome Description:
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.
Outcome Time Frame:
Up to 3 years
Safety Issue:
No
Principal Investigator
Cornelia Trimble
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gynecologic Oncology Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02513
NCT ID:
NCT00054041
Start Date:
June 2004
Completion Date:
Related Keywords:
- Cervical Cancer
- Cervical Intraepithelial Neoplasia Grade 3
- Human Papilloma Virus Infection
- Neoplasms
- Uterine Cervical Neoplasms
- Papilloma
- Virus Diseases
- Cervical Intraepithelial Neoplasia
- Warts
- Carcinoma in Situ
- Papillomavirus Infections
Name | Location |
|---|---|
| Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |
