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Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054041
First received: February 5, 2003
Last updated: January 23, 2013
Last verified: January 2013
History of Changes

February 5, 2003
January 23, 2013
June 2004
January 2007   (final data collection date for primary outcome measure)
  • Complete histologic regression of all CIN 3 lesions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.
  • Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00054041 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

PRIMARY OBJECTIVES:

I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine change in lesion size in these patients after treatment with this drug.

II. Compare histologic response before and after treatment with this drug in these patients.

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

Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.

Arm II: Patients receive standard care.

At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia Grade 3
  • Human Papilloma Virus Infection
  • Biological: HspE7
    Given subcutaneously
    Other Names:
    • HPV 16 E7/HSP65 Vaccine
    • HPV E7 Peptide Epitope Vaccine
    • SGN-00101
  • Procedure: therapeutic conventional surgery
    Undergo large loop excision
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I (HspE7)
    Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
    Interventions:
    • Biological: HspE7
    • Procedure: therapeutic conventional surgery
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (control)
    Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
    Interventions:
    • Procedure: therapeutic conventional surgery
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
Not Provided
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed grade III cervical intraepithelial neoplasia

    • Confirmed by biopsy or colposcopy
  • Positive for human papilloma virus 16
  • No endocervical glandular dysplasia
  • No adenocarcinoma in situ
  • Performance status - GOG 0-2
  • No life-threatening or serious hematological disorder
  • No life-threatening or serious hepatic disorder
  • No life-threatening or serious renal disorder
  • No life-threatening or serious cardiac disorder
  • No life-threatening or serious respiratory disorder
  • HIV negative
  • Must be immunocompetent
  • No history of autoimmune disease
  • No life-threatening or serious immunological disorder
  • No prior or concurrent severe allergic disease
  • No concurrent human papilloma viral infection other than type 16
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No life-threatening or serious gastrointestinal disorder
  • No life-threatening or serious endocrine disorder
  • No invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No concurrent chronic or systemic steroids
  • No prior organ transplantation
  • No prior cancer therapy that would preclude study therapy
Female
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054041
NCI-2012-02513, GOG-0197, U10CA027469, CDR0000269709
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Cornelia Trimble Gynecologic Oncology Group
National Cancer Institute (NCI)
January 2013

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