SGN-00101 (HspE7) Immunotherapy Of CIN III
18 Years
N/A
Female
Cervical Cancer, Precancerous Condition
Trial Information
SGN-00101 (HspE7) Immunotherapy Of CIN III
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Rate of regression at 4-7 months after completion of treatment
Safety Issue:
No
Principal Investigator
Carolyn D. Runowicz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Connecticut Health Center
Authority:
United States: Federal Government
Study ID:
CDR0000347077
NCT ID:
NCT00075569
Start Date:
March 2004
Completion Date:
Related Keywords:
- Cervical Cancer
- Precancerous Condition
- cervical cancer
- cervical intraepithelial neoplasia grade 3
- Uterine Cervical Neoplasms
- Precancerous Conditions
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
Name | Location |
|---|---|
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
