Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line (KS2422) (KS2422-vacc)
Phase 1 Study: Induction of Systemic Immune Responses in Metastatic Breast Cancer Patients by Vaccination With a CD80-modified, Devitalized HLA-*A0201+ Breast Cancer Cell Line (KS24.22)
연구 개요
상세 설명
The trial was designed as an open label phase-I. Informed consent was given twice by the patients (1st for HLA-typing, 2nd for participation in the vaccination trial).
The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD).
Immediately before administration, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Tuebingen, 독일, 72076
- Univ. of Tuebingen, Dep. Obst. and Gynecology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- proven diagnosis of carcinoma of the breast with distant metastatic disease
- patient received either anthracycline- or taxane-based chemotherapy ("state of the art")
- Karnofsky Score (performance status) 80%
- HLA-*A0201-positive
- minimum life expectancy of 6 month
- written informed consent
- activation of patient's T-lymphocytes by mitogen antibodies and the cell line used for vaccination
Exclusion Criteria:
- manifestation of CNS metastases
- immunosuppressive disease like AIDS, autoimmune disease
- no serious concomitant systemic medical disorders or active acute or systemic infection
- pregnancy
- chemotherapies or radiotherapies in the 4 weeks preceding study entry
- biological response modifiers (antibodies, TNF, cytokines) or other immune therapies in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors)
- organ transplanted patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: KS24.22-vaccination
The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD). Immediately before administration, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites. |
The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD). Immediately before administration, KS24.22 cells were thawed and lethally irradiated (200 gray). KS24.22 cells were adjusted to 107/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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실행할 수 있음
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safety of KS24.22 administration
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
기간 |
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전반적인 생존
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무진행 생존
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면역 반응
기간: 2 년
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2 년
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공동 작업자 및 조사자
수사관
- 수석 연구원: Diethelm Wallwiener, University Hospital Tuebingen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
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