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Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer Clinical research trials and Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer clinical trial. Human subjects often get the best healthcare possible for their Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer  Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
For Condition: stage 1B cervical cancer,stage 2A cervical cancer,cervical squamous cell carcinoma,cervical adenosquamous cell carcinoma,cervical adenocarcinoma
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: 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: Phase II trial to study the effectiveness of vaccine therapy made from human papillomavirus plus surgery in treating patients with early cervical cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElaineRankin, Study Chair, Ninewells Hospital and Medical School
University Hospital of Linkoping *Recruiting*
Linkoping, , S-581 85
Sweden
Recruiting Anika Hakansson 46-13-222-000
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting M. Adams 44-29-2061-5888
Institut Jules Bordet *Recruiting*
Brussels (Bruxelles), , 1000
Belgium
Recruiting Joseph Kerger 32-2-535-4865
Innsbruck Universitaetsklinik *Recruiting*
Innsbruck, , A-6020
Austria
Recruiting Heinz Zwierzina 43-512-504-3255
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen *Recruiting*
Munich, , D-80337
Germany
Recruiting H. Sommer 49-89-5160-4313
Universitats Klinikum Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting T. Bauknecht 49-761-270-3165
University Medical Center Nijmegen *Recruiting*
Nijmegen, , 6500
Netherlands
Recruiting Pieter de Mulder 31-24-361-1111
St. Mary's Hospital *Recruiting*
Manchester, England, M13 0JH
United Kingdom
Recruiting H.C. Kitchener 44-161-276-6461
Institut Curie - Section Medicale *Recruiting*
Paris, , 75248
France
Recruiting Susan Scholl 33-44-32-4100
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting Elaine Rankin 44-1382-425-543
Additional Information:
Study ID Numbers: CDR0000065295; EORTC-13961
Study Start Date:
Record last reviewed: April 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002916
Other Stage 2a Cervical Cancer Studies:
1. Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
2. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
3. Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
4. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
Related Studies:
Other stage 2A cervical cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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