©2024 Stanford Medicine
Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer
Not Recruiting
Trial ID: NCT01943188
Purpose
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.
Official Title
Pilot Study of Local Tumor Irradiation With Autologous T-Cell Infusion for Metastatic Renal Cell Carcinoma
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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
Intervention(s):
radiation: stereotactic body radiation therapy
drug: cyclophosphamide
biological: therapeutic autologous lymphocytes
other: laboratory biomarker analysis
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061