- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003086
Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer
Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer
RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating women who have stage IV breast cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.
OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Louisiana
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Shreveport, Louisiana, 미국, 71130-3932
- Louisiana State University School of Medicine
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참여기준
자격 기준
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건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Adequate peripheral blood stem cells harvested and stored
PATIENT CHARACTERISTICS: Age: 21-65 Sex: Female Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction of at least 50% No symptomatic coronary artery disease Pulmonary: FEV1 and DLCO greater than 50% of predicted Other: Not pregnant Not HIV positive Not hepatitis B surface antigen positive No uncontrolled infection No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix Curatively treated nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior therapy Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for metastatic disease Surgery: Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Benjamin B. Weinberger, MD, Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LSU-97447
- CDR0000065786 (레지스트리 식별자: PDQ (Physician Data Query))
- NCI-V97-1341
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