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

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075569

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.

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

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Prevention
Official Title:	SGN-00101 (HspE7) Immunotherapy Of CIN III

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Rate of regression at 4-7 months after completion of treatment [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Study Start Date:

March 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.
Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.
Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.

Secondary

Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine
Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.
Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.
Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.

All patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity.

Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy.
Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy.

Patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination.

PROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) 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 III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions
No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm^3
Lymphocyte count at least 500/mm^3
Platelet count at least 150,000/mm^3
Hemoglobin at least 10 g/dL
No significant hematologic disease that is uncontrolled with standard therapy

Hepatic

Bilirubin no greater than 2 mg/dL
Liver enzymes no greater than 2.5 times normal
No significant hepatic disease that is uncontrolled with standard therapy

Renal

Creatinine no greater than 2 mg/dL
No significant renal disease that is uncontrolled with standard therapy

Cardiovascular

No significant cardiovascular disease that is uncontrolled with standard therapy

Pulmonary

No significant respiratory disease that is uncontrolled with standard therapy
No history of asthma

Immunologic

HIV negative
No clinical evidence of immunosuppression
No autoimmune disease
No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study
No history of a positive purified protein derivative (PPD) or Tine test

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile
No uncontrolled chronic disease
- Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs
No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy
No other underlying or unstable disease that would be exacerbated by the study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior BCG vaccination
No other concurrent vaccine therapy

Chemotherapy

No concurrent chemotherapy

Endocrine therapy

More than 30 days since prior oral or parenteral glucocorticoid steroid

Radiotherapy

Not specified

Surgery

Not specified

Other

More than 30 days since prior participation in another investigational study
No concurrent cytotoxic therapy
No other concurrent investigational agents
No other concurrent investigational or commercial agents or therapies intended to treat CIN

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075569

Locations

United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Study Chair:	Carolyn D. Runowicz, MD	University of Connecticut Health Center
Investigator:	Mark H. Einstein, MD, MS	Albert Einstein College of Medicine of Yeshiva University

More Information

Additional Information:

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

Publications:

Einstein MH, Kadish AS, Burk RD, Kim MY, Wadler S, Streicher H, Goldberg GL, Runowicz CD. Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III. Gynecol Oncol. 2007 Sep;106(3):453-60. Epub 2007 Jun 22.

ClinicalTrials.gov Identifier:	NCT00075569 History of Changes
Other Study ID Numbers:	CDR0000347077, AECM-0309225, NCI-5850
Study First Received:	January 9, 2004
Last Updated:	January 27, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Disease
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2012