SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060099
First received: May 6, 2003
Last updated: November 5, 2013
Last verified: March 2005
  Purpose

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 Intervention Phase
Precancerous Condition
Biological: HspE7
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060099

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber/Brigham and Women's Cancer Center
Investigators
Study Chair: Kristin A. Keefe, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00060099     History of Changes
Other Study ID Numbers: CDR0000299462, BWH-000-P-CONS01, NCI-3074
Study First Received: May 6, 2003
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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:
Neoplasms
Precancerous Conditions
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2014