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

January 23, 2013 updated by: National Cancer Institute (NCI)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

84

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Gynecologic Oncology Group

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

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: laboratory biomarker analysis
Correlative studies
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
Experimental: Arm II (control)
Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Other: laboratory biomarker analysis
Correlative studies
Procedure: therapeutic conventional surgery
Undergo large loop excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete histologic regression of all CIN 3 lesions
Time Frame: Up to 3 years
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.
Up to 3 years
Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cornelia Trimble, Gynecologic Oncology Group

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

June 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02513
  • U10CA027469 (U.S. NIH Grant/Contract)
  • GOG-0197
  • CDR0000269709 (Registry Identifier: PDQ (Physician Data Query))

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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