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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075569
First received: January 9, 2004
Last updated: January 27, 2010
Last verified: January 2006
  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 2

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:


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
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:
Publications:
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
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014