SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

November 5, 2013 updated by: Dana-Farber/Brigham and Women's Cancer Center

Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III

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

PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia.
  • Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug.

OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision.

PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed grade II or III cervical intraepithelial neoplasia

    • Confirmed by colposcopy-directed punch biopsy

  • Accessible, definable, and entirely visible cervical lesions persisting after biopsy

    • Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy
  • Positive for human papilloma virus 16
  • CD4+ counts normal

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0

Life expectancy

  • Not specified

Hematopoietic

  • No coagulation disorder that requires medical intervention

Hepatic

  • Hepatitis B core antigen negative
  • Hepatitis C antibody negative

Renal

  • Not specified

Cardiovascular

  • No cardiovascular disorder that requires medical intervention

Pulmonary

  • No respiratory disorder that requires medical intervention

Immunologic

  • HIV negative
  • Not immunologically compromised
  • No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen

  • No immunological disorders including any of the following:

    • Lupus
    • Diabetes
    • Multiple sclerosis
    • Myasthenia gravis
  • No active systemic infections that require medical intervention

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to undergo a loop electrosurgical excision procedure
  • No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance
  • No other prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy
  • No other concurrent gene therapy
  • No concurrent biologic therapy

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • More than 30 days since prior systemic steroid therapy

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational drugs
  • No other concurrent investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber/Brigham and Women's Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kristin A. Keefe, MD, Dana-Farber/Brigham and Women's Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000299462
  • BWH-000-P-CONS01
  • NCI-3074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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