Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer
Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Conduct a safety and feasibility study of stereotactic radiotherapy with autologous T-cell infusion for patients with metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. Determine the progression free survival at one year. II. Determine the overall survival at one year.
OUTLINE:
STEREOTACTIC BODY RADIATION THERAPY (SBRT): Patients undergo standard of care SBRT over 1-2 weeks according to tumor volume and location.
LYMPHODEPLETION: Beginning 3 weeks later, patients receive cyclophosphamide orally (PO) twice daily (BID) for 3 days.
REINFUSION OF PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC): Within 3-14 days of completing lymphodepletion with cyclophosphamide, patients undergo autologous PBMC infusion.
After completion of study treatment, patients are followed up at 1 week, 4 weeks, and monthly thereafter.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Stanford, California, 미국, 94305
- Stanford University Hospitals and Clinics
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically confirmed carcinoma of the kidney (clear-cell predominance)
- Have had at least 2 prior systemic treatments for renal cell carcinoma (RCC)
- Have at least 1 extracranial metastasis that is amenable to radiation and at least 1 other site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Absolute neutrophil count (ANC) >= 0.75 x 10^9/L
- Absolute lymphocyte count (ALC) >= 0.5 X 10^9/L
- Hemoglobin >= 8 g/dL
- Platelets >= 50 X 10^9/L
- Total bilirubin =< 3 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 X ULN
- Serum creatinine =< 2.1 X ULN (or creatinine clearance of > 50 cc/min)
Exclusion Criteria:
History of other malignancies within 5 years prior to enrollment except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
- Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to enrollment may be discussed with the lead primary investigator
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for more than 1 week within 6 months prior enrollment
- Presence of uncontrolled infection
- Evidence of active bleeding or bleeding diathesis; any medical condition requiring systemic anticoagulation (including anti-platelet agents)
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to procedures
- Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study
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 |
|---|---|
|
실험적: Treatment (SBRT, autologous PBMC infusion)
SBRT: Patients undergo standard of care SBRT over 1-2 weeks according to tumor volume and location. LYMPHODEPLETION: Beginning 3 weeks later, patients receive cyclophosphamide PO BID for 3 days. REINFUSION OF PBMC: Within 3-14 days of completing lymphodepletion with cyclophosphamide , patients undergo autologous PBMC infusion. |
상관 연구
주어진 PO
다른 이름들:
SBRT 진행
다른 이름들:
Undergo autologous PBMC infusion
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of treatment-related grade 3-5 toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
기간: Within 30 days after infusion of PBMCs
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Adverse events will be tabulated by type and grade at each follow-up interval.
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Within 30 days after infusion of PBMCs
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall survival (OS)
기간: 1 year
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The level of OS will be tabulated at each follow-up interval, and will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals.
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1 year
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Progression-free survival (PFS)
기간: The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
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The level of PFS will be tabulated at each follow-up interval.
The percentage of individuals free from disease progression will be computed with exact 95% confidence intervals.
PFS will be summarized using Kaplan-Meier curves and medians with 95% confidence intervals.
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The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Level of circulating tumor cells (CTCs)
기간: Up to 2 years
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The correlations of CTCs and changes in signaling as measured by nano-immunoassay (NIA) to clinical response will be assessed.
NIA measurements for 20 protein isoforms will be analyzed.
Measurements will be analyzed as continuous variables for each sample.
The distribution of each isoform will be summarized with medians and interquartile ranges.
Quantile plot and box-Cox models will be used to determine whether to transform the data prior to analysis.
A protein isoform signature predictive of clinical response will be constructed using the Lasso R glmnet package.
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Up to 2 years
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Changes in signaling as measured by NIA
기간: Up to 2 years
|
The correlations of CTCs and changes in signaling as measured by NIA to clinical response will be assessed.
NIA measurements for 20 protein isoforms will be analyzed.
Measurements will be analyzed as continuous variables for each sample.
The distribution of each isoform will be summarized with medians and interquartile ranges.
Quantile plot and box-Cox models will be used to determine whether to transform the data prior to analysis.
A protein isoform signature predictive of clinical response will be constructed using the Lasso R glmnet package.
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Up to 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sandy Srinivas, Stanford University Hospitals and Clinics
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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
추가 관련 MeSH 약관
기타 연구 ID 번호
- RENAL0027 (기타 식별자: Stanford University Hospitals and Clinics)
- P30CA124435 (미국 NIH 보조금/계약)
- NCI-2013-01688 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
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