Back to resultsSurgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
human papillomavirus 16 E7 peptide
synthetic human papillomavirus 16 E6 peptide
adjuvant therapy
surgical procedure
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage IB cervical cancer, stage IIA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision No CNS metastases Circulating CD4+ lymphocyte count at least 400 Proven absence of hepatitis B and C antibodies Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed Reaction to 2 or more antigens on Pasteur Merieux CMI test required Ability to collaborate planned follow-up required PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO/ECOG no greater than 2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,000 (3,000 x 10 to the ninth/L) Platelet count greater than 120,000 (120 x 10 to the ninth/L) No bleeding disorder Hepatic: Bilirubin less than 1.5 times normal AST and ALT less than 1.5 times normal Prothrombin or partial thromboplastin time no greater than 2 times normal Renal: Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: No ongoing infection No HIV antibody No serious medical or psychiatric illness No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy Not pregnant or nursing Adequate contraception required Patient or her household contacts must not have any of the following: Chronic steroid therapy Renal or other allograft Known immunodeficiency Eczema Children under 5 years old PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Sites / Locations
- Innsbruck Universitaetsklinik
- Institut Curie - Section Medicale
- Universitaetsklinikum Freiburg
- I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
- Nijmegen Cancer Center at Radboud University Medical Center
- Norwegian Radium Hospital
- University Hospital of Linkoping
- St. Mary's Hospital
- Ninewells Hospital and Medical School
- Velindre Cancer Center at Velinde Hospital
Outcomes
Primary Outcome Measures
Immunological response to HPV
Toxicity and safety of TA-HPV
Secondary Outcome Measures
Proliferative capacity of T-cells to the E6 and E7 proteins
Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
Full Information
NCT ID
NCT00002916
First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00002916
Brief Title
Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
Official Title
A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.
Detailed Description
OBJECTIVES:
Evaluate the systemic immunological response to the human papilloma virus vaccine (TA-HPV) expressing the proteins 16, 18, E6 and E7 examining the cytolytic T cell and the antibody responses in cervical cancer patients.
Investigate further the safety and toxic effects of TA-HPV in these patients.
Assess the proliferative capacity of T cells to the E6 and E7 proteins.
Observe any influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive 2 vaccinations of the human papilloma virus with proteins 16, 18, E6 and E7 at least 4 weeks apart, with the first vaccination at least 2 weeks before surgery and the second 8 weeks after the first one, unless unacceptable toxicity occurs. Patients who require radiotherapy following surgery receive their second vaccination 4-8 weeks after the first vaccination.
Twenty-eight patients are entered initially; if at least 2 patients show an immunologic response, 16 additional patients are entered.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually.
PROJECTED ACCRUAL: 44 patients will be entered over 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage IB cervical cancer, stage IIA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
human papillomavirus 16 E7 peptide
Intervention Type
Biological
Intervention Name(s)
synthetic human papillomavirus 16 E6 peptide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Immunological response to HPV
Title
Toxicity and safety of TA-HPV
Secondary Outcome Measure Information:
Title
Proliferative capacity of T-cells to the E6 and E7 proteins
Title
Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision
No CNS metastases
Circulating CD4+ lymphocyte count at least 400
Proven absence of hepatitis B and C antibodies
Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed
Reaction to 2 or more antigens on Pasteur Merieux CMI test required
Ability to collaborate planned follow-up required
PATIENT CHARACTERISTICS:
Age:
19 and over
Performance status:
WHO/ECOG no greater than 2
Life expectancy:
At least 3 months
Hematopoietic:
WBC greater than 3,000 (3,000 x 10 to the ninth/L)
Platelet count greater than 120,000 (120 x 10 to the ninth/L)
No bleeding disorder
Hepatic:
Bilirubin less than 1.5 times normal
AST and ALT less than 1.5 times normal
Prothrombin or partial thromboplastin time no greater than 2 times normal
Renal:
Creatinine less than 1.3 mg/dL (120 micromoles/L)
Other:
No ongoing infection
No HIV antibody
No serious medical or psychiatric illness
No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy
Not pregnant or nursing
Adequate contraception required
Patient or her household contacts must not have any of the following:
Chronic steroid therapy
Renal or other allograft
Known immunodeficiency
Eczema
Children under 5 years old
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine M. Rankin, MD
Organizational Affiliation
Ninewells Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Innsbruck Universitaetsklinik
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-80337
Country
Germany
Facility Name
Nijmegen Cancer Center at Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
St. Mary's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M13 0JH
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velinde Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
12. IPD Sharing Statement
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Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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