Stereotactic Body Radiation Therapy and T-Cell Infusion in Treating Patients With Metastatic Kidney Cancer

Not Recruiting

Trial ID: NCT01943188


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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

   - 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


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

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