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SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060099
Recruitment Status : Unknown
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2003
Last Update Posted : November 6, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Precancerous Condition Biological: HspE7 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
Study Start Date : May 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0

Life expectancy

  • Not specified


  • No coagulation disorder that requires medical intervention


  • Hepatitis B core antigen negative
  • Hepatitis C antibody negative


  • Not specified


  • No cardiovascular disorder that requires medical intervention


  • No respiratory disorder that requires medical intervention


  • 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


  • 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


Biologic therapy

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


  • No concurrent chemotherapy

Endocrine therapy

  • More than 30 days since prior systemic steroid therapy


  • No concurrent radiotherapy


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060099

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
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Study Chair: Kristin A. Keefe, MD Dana-Farber/Brigham and Women's Cancer Center
Layout table for additonal information Identifier: NCT00060099    
Other Study ID Numbers: CDR0000299462
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: March 2005
Keywords provided by National Cancer Institute (NCI):
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
human papilloma virus infection
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Precancerous Conditions
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type