Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Nijmegen, 네덜란드, 6500
- Nijmegen Cancer Center at Radboud University Medical Center
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Oslo, 노르웨이, N-0310
- Norwegian Radium Hospital
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Freiburg, 독일, D-79106
- Universitaetsklinikum Freiburg
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Munich, 독일, D-80337
- I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
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Linkoping, 스웨덴, S-581 85
- University Hospital of Linkoping
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England
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Manchester, England, 영국, M13 0JH
- St. Mary's Hospital
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Scotland
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Dundee, Scotland, 영국, DD1 9SY
- Ninewells Hospital and Medical School
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Wales
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Cardiff, Wales, 영국, CF14 2TL
- Velindre Cancer Center at Velinde Hospital
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Innsbruck, 오스트리아, A-6020
- Innsbruck Universitaetsklinik
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Paris, 프랑스, 75248
- Institut Curie - Section Medicale
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Immunological response to HPV
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Toxicity and safety of TA-HPV
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2차 결과 측정
결과 측정 |
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Proliferative capacity of T-cells to the E6 and E7 proteins
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Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
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공동 작업자 및 조사자
수사관
- 연구 의자: Elaine M. Rankin, MD, Ninewells Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EORTC-13961
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