Cervical CancerPhase 2NCT00002916
Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
A Phase 2 study testing human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide and adjuvant therapy in people with Cervical Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Nov 1996to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
United Kingdom3 sites
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF14 2TL
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
St. Mary's Hospital
Manchester, England, M13 0JH
Germany2 sites
Universitaetsklinikum Freiburg
Freiburg im Breisgau, D-79106
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, D-80337
Netherlands1 site
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, 6500
About this study
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
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide, adjuvant therapy, surgical procedure, radiation therapy
- Keywords
- stage IB cervical cancer, stage IIA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human papillomavirus 16 E7 peptideBiological
synthetic human papillomavirus 16 E6 peptideBiological
adjuvant therapyProcedure or surgery
surgical procedureProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological response to HPV
Toxicity and safety of TA-HPV
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elaine M. Rankin, MD, Study chair, Ninewells Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002916
- Sponsor's protocol ID
- EORTC-13961
- Other IDs
- EORTC-13961
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002916
- Acronym / sponsor ID
- EORTC-13961
- Conditions
- Cervical Cancer
- Keywords
- stage IB cervical cancer, stage IIA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Nov 1996
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human papillomavirus 16 E7 peptide | Biological | – |
| synthetic human papillomavirus 16 E6 peptide | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
| surgical procedure | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Immunological response to HPV
Toxicity and safety of TA-HPV
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine M. Rankin, MD study chair
Ninewells Hospital
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide and adjuvant therapy in people with Cervical Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Germany, Austria, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological response to HPV. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.