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SGN-00101 (HspE7) Immunotherapy Of CIN III


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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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 MedicineBronx, New York  10461
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021