Biological Therapy in Treating Patients With Metastatic Cancer
A Phase I Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Human Cultured Dendritic Cells in Patients With Metastatic Malignancies Expressing Carcinoembryonic Antigen
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.
연구 개요
상태
상세 설명
OBJECTIVES: I. Determine the safety and dose limiting toxicity of an intravenous vaccine of autologous, cultured, dendritic cells pulsed with carcinoembryonic antigen (CEA) RNA in patients with metastatic adenocarcinoma expressing CEA. II. Assess the cellular immune response to the CEA protein. III. Assess the clinical and biochemical response to the treatment and the duration of such response.
OUTLINE: This a three tiered, open label, uncontrolled, dose escalation study. The first 3 patients receive a low dose of intravenous carcinoembryonic antigen (CEA) RNA-pulsed autologous dendritic cells (DC) at weeks 0, 1, 2, and 3. Patients are evaluated for dose limiting toxicity (DLT), immune response, and the antitumor response for at least 1 week before dose escalation may proceed. If there is no DLT in the first three, the next 3 patients are treated at a medium dose of CEA RNA-pulsed autologous DC at 0, 1, 2, and 3 weeks. Finally, if DLT is not seen at the medium dose, the final 6 patients receive intravenous infusions of a high dose of CEA RNA-pulsed autologous DC at weeks 0, 1, 2, and 3. If 1-2 patient(s) experience DLT at the either the low or medium dose levels, 3 more patients are entered at the same dose. If no further DLT occurs, then dose escalation continues. As soon as 3 toxic events occur in 3-6 patients at one dose level, accrual at that level ceases. The MTD is defined as the dose level immediately below that at which more than 3 of 6 patients develop DLT.
PROJECTED ACCRUAL: A minimum of 3 and a maximum of 18 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma expressing carcinoembryonic antigen (CEA) that has failed conventional therapy Measurable or evaluable disease May include elevated CEA level No previously irradiated or known new CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 PT less than 1.25 times normal limit PTT less that 1.66 times normal limit Fibrinogen greater than 0.75 times normal limit Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No NYHA class III or IV Pulmonary: FEV1 greater than 70% of predicted FVC greater than 70% of predicted DLCO greater than 70% of predicted No asthma or chronic obstructive pulmonary disease Other: No active or chronic infection (including urinary tract infection) No viral hepatitis HIV negative No concurrent second malignancy other than nonmelanoma skin cancer or controlled superficial bladder cancer No hepatic disease No history of other autoimmune disease such as inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis
PRIOR CONCURRENT THERAPY: Must have recovered from all acute toxic effects Biologic therapy: No concurrent biologic therapy At least 6 weeks since biologic therapy No concurrent immunotherapy No more than 1 prior biologic regimen Chemotherapy: No concurrent chemotherapy At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen Endocrine therapy: At least 6 weeks since steroid therapy Radiotherapy: No concurrent radiotherapy At least 12 weeks since therapy including Sr 89 At least 6 weeks since other radiotherapy No prior cranial radiotherapy Surgery: Not specified Other: No concurrent immunosuppressives such as azathioprine or cyclosporine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CEA RNA-pulsed DC cancer vaccine
carcinoembryonic antigen RNA-pulsed dendritic cells
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carcinoembryonic antigen RNA-pulsed dendritic cells
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety
기간: 12 months
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To determine the safety and dose limiting toxicity of intravenous injections of autologous, cultured, dendritic cells pulsed with CEA RNA.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immune response
기간: 12 weeks
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Evaluation of cellular immune response to the CEA protein.
Evaluation of clinical and biochemical response to the treatment and the duration of such response
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12 weeks
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공동 작업자 및 조사자
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
이 연구와 관련된 용어
키워드
- 3기 악성 고환 생식 세포 종양
- 4기 유방암
- 재발성 유방암
- 재발성 비소세포폐암
- 광범위한 병기의 소세포 폐암
- 재발성 소세포 폐암
- 4기 비소세포 폐암
- 재발성 침샘암
- 4기 침샘암
- IV기 직장암
- 4기 결장암
- 재발성 결장암
- 재발성 직장암
- 재발성 췌장암
- 4기 난소 상피암
- 재발성 난소 상피암
- 남성 유방암
- 4기 췌장암
- 간 전이
- 4기 위암
- 재발성 위암
- 절제 불가능한 담낭암
- 재발성 담낭암
- 절제 불가능한 간외 담관암
- 재발성 간외 담관암
- 담낭의 담관암종
- 간외 담관의 담관암종
- 염증성 유방암
- 재발성 악성 고환 생식 세포 종양
- 고환 난황낭 종양
- 성인 원발성 간세포 암종
- 갑상선 수질 암종
- 침윤성 관 암종을 동반한 유방의 파제트병
- 폐 전이
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000065619
- 1817 (기타 식별자: Duke IRB)
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