Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT01943188|
Recruitment Status : Terminated
First Posted : September 16, 2013
Last Update Posted : March 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer||Radiation: stereotactic body radiation therapy Drug: cyclophosphamide Biological: therapeutic autologous lymphocytes Other: laboratory biomarker analysis||Phase 1|
I. Conduct a safety and feasibility study of stereotactic radiotherapy with autologous T-cell infusion for patients with metastatic renal cell carcinoma.
I. Determine the progression free survival at one year. II. Determine the overall survival at one year.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2016|
Experimental: 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.
Radiation: stereotactic body radiation therapy
Biological: therapeutic autologous lymphocytes
Undergo autologous PBMC infusion
Other: laboratory biomarker analysis
- 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 [ Time Frame: Within 30 days after infusion of PBMCs ]Adverse events will be tabulated by type and grade at each follow-up interval.
- Overall survival (OS) [ Time Frame: 1 year ]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.
- Progression-free survival (PFS) [ Time Frame: The duration from SBRT treatment to documented disease progression or death, assessed at 1 year ]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.
- Level of circulating tumor cells (CTCs) [ Time Frame: Up to 2 years ]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.
- Changes in signaling as measured by NIA [ Time Frame: 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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943188
|United States, California|
|Stanford University Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandy Srinivas||Stanford University Hospitals and Clinics|
|Responsible Party:||Sandy Srinivas, Professor of Medicine, Stanford University|
|Other Study ID Numbers:||
NCI-2013-01688 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RENAL0027 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( U.S. NIH Grant/Contract )
|First Posted:||September 16, 2013 Key Record Dates|
|Last Update Posted:||March 15, 2017|
|Last Verified:||March 2017|
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action