SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber/Brigham and Women's Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060099
First received: May 6, 2003
Last updated: February 1, 2010
Last verified: March 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Precancerous Condition |
Biological: HspE7 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | May 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060099
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber/Brigham and Women's Cancer Center
Investigators
| Study Chair: | Kristin A. Keefe, MD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00060099 History of Changes |
| Other Study ID Numbers: | CDR0000299462, BWH-000-P-CONS01, NCI-3074 |
| Study First Received: | May 6, 2003 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 human papilloma virus infection |
Additional relevant MeSH terms:
|
Neoplasms Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013