search
Back to results

SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

Primary Purpose

Precancerous Condition

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HspE7
Sponsored by
Dana-Farber/Brigham and Women's Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precancerous Condition focused on measuring cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed grade II or III cervical intraepithelial neoplasia Confirmed by colposcopy-directed punch biopsy Accessible, definable, and entirely visible cervical lesions persisting after biopsy Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy Positive for human papilloma virus 16 CD4+ counts normal PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0 Life expectancy Not specified Hematopoietic No coagulation disorder that requires medical intervention Hepatic Hepatitis B core antigen negative Hepatitis C antibody negative Renal Not specified Cardiovascular No cardiovascular disorder that requires medical intervention Pulmonary No respiratory disorder that requires medical intervention Immunologic HIV negative Not immunologically compromised No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen No immunological disorders including any of the following: Lupus Diabetes Multiple sclerosis Myasthenia gravis No active systemic infections that require medical intervention Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Willing to undergo a loop electrosurgical excision procedure No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No other concurrent gene therapy No concurrent biologic therapy Chemotherapy No concurrent chemotherapy Endocrine therapy More than 30 days since prior systemic steroid therapy Radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 30 days since prior investigational drugs No other concurrent investigational drugs

Sites / Locations

  • Brigham and Women's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
November 5, 2013
Sponsor
Dana-Farber/Brigham and Women's Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00060099
Brief Title
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
Official Title
Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber/Brigham and Women's Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia. PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
Detailed Description
OBJECTIVES: Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia. Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug. OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision. PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition
Keywords
cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HspE7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed grade II or III cervical intraepithelial neoplasia Confirmed by colposcopy-directed punch biopsy Accessible, definable, and entirely visible cervical lesions persisting after biopsy Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy Positive for human papilloma virus 16 CD4+ counts normal PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0 Life expectancy Not specified Hematopoietic No coagulation disorder that requires medical intervention Hepatic Hepatitis B core antigen negative Hepatitis C antibody negative Renal Not specified Cardiovascular No cardiovascular disorder that requires medical intervention Pulmonary No respiratory disorder that requires medical intervention Immunologic HIV negative Not immunologically compromised No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen No immunological disorders including any of the following: Lupus Diabetes Multiple sclerosis Myasthenia gravis No active systemic infections that require medical intervention Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Willing to undergo a loop electrosurgical excision procedure No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No other concurrent gene therapy No concurrent biologic therapy Chemotherapy No concurrent chemotherapy Endocrine therapy More than 30 days since prior systemic steroid therapy Radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 30 days since prior investigational drugs No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin A. Keefe, MD
Organizational Affiliation
Dana-Farber/Brigham and Women's Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

We'll reach out to this number within 24 hrs