SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia - Full Text View

Sponsor:	Dana-Farber/Brigham and Women's Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00060099

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 II

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2003

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.

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Kristin A. Keefe, MD

Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:

Disease
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Pathologic Processes

Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 13, 2012