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

Primary Purpose

Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HspE7
therapeutic conventional surgery
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (HspE7)

Arm II (control)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Complete histologic regression of all CIN 3 lesions
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

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054041
Brief Title
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Official Title
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (HspE7)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (control)
Arm Type
Experimental
Arm Description
Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Intervention Type
Biological
Intervention Name(s)
HspE7
Other Intervention Name(s)
HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101
Intervention Description
Given subcutaneously
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo large loop excision
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Complete histologic regression of all CIN 3 lesions
Description
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.
Time Frame
Up to 3 years
Title
Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Trimble
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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