Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia - Full Text View

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054041

Purpose

RATIONALE: 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.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

Condition	Intervention	Phase
Cervical Cancer Precancerous/Nonmalignant Condition	Biological: HspE7	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Complete histologic regression [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Designated as safety issue: Yes ]

Study Start Date:	June 2004
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
Determine the toxicity of this drug in these patients.

Secondary

Determine change in lesion size in these patients after treatment with this drug.
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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

17 and over

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

No life-threatening or serious hematological disorder

Hepatic

No life-threatening or serious hepatic disorder

Renal

No life-threatening or serious renal disorder

Cardiovascular

No life-threatening or serious cardiac disorder

Pulmonary

No life-threatening or serious respiratory disorder

Immunologic

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

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No concurrent chronic or systemic steroids

Radiotherapy

Not specified

Surgery

No prior organ transplantation

Other

No prior cancer therapy that would preclude study therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054041

Locations

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Cornelia L. Trimble, MD

Sidney Kimmel Comprehensive 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

Study ID Numbers:	CDR0000269709, GOG-0197
Study First Received:	February 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00054041 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 3
human papilloma virus infection

Study placed in the following topic categories:

Virus Diseases
Precancerous Conditions
Carcinoma in Situ
Papillomavirus Infections

Papilloma
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on July 06, 2009