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
3 other identifiers
interventional
2
1 country
1
Brief Summary
This pilot phase I trial studies the side effects and best way to give stereotactic body radiation therapy and T-cell infusion in treating patients with metastatic kidney cancer. Giving total body irradiation before a T-cell infusion stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. Chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedMarch 15, 2017
March 1, 2017
1.8 years
September 11, 2013
March 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Adverse events will be tabulated by type and grade at each follow-up interval.
Within 30 days after infusion of PBMCs
Secondary Outcomes (2)
Overall survival (OS)
1 year
Progression-free survival (PFS)
The duration from SBRT treatment to documented disease progression or death, assessed at 1 year
Other Outcomes (2)
Level of circulating tumor cells (CTCs)
Up to 2 years
Changes in signaling as measured by NIA
Up to 2 years
Study Arms (1)
Treatment (SBRT, autologous PBMC infusion)
EXPERIMENTALSBRT: 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.
Interventions
Undergo SBRT
Given PO
Undergo autologous PBMC infusion
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Stanford University Hospitals and Clinics
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandy Srinivas
Stanford University Hospitals and Clinics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 16, 2013
Study Start
May 1, 2014
Primary Completion
March 1, 2016
Last Updated
March 15, 2017
Record last verified: 2017-03