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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE May 6, 2003
First Posted Date  ICMJE May 7, 2003
Last Update Posted Date November 6, 2013
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
Official Title  ICMJE Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Precancerous Condition
Intervention  ICMJE Biological: HspE7
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060099
Other Study ID Numbers  ICMJE CDR0000299462
BWH-000-P-CONS01
NCI-3074
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Dana-Farber/Brigham and Women's Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Kristin A. Keefe, MD Dana-Farber/Brigham and Women's Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP