RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.
OBJECTIVES: Primary * To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors. Secondary * To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates. Serum Blood Marker Objective: * To determine if serum markers collected before and after radiation may give a predictive indication of tumor response. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present. After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.
At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
UH-Chagrin Highlands
Orange, Ohio, United States
UH-Westlake
Westlake, Ohio, United States
Maximum Tolerated Dose of Radiosurgery
Dose escalation stops if 2/4 (50%) or 3/8 (37.5%) of participants experience DLTs in a given dose level cohort. The maximum tolerated dose will be one dose level below which the DLTs were exceeded.
Time frame: once every 4 weeks
Overall Survival
Radiographic efficacy as measured by overall (percent of participants still alive after study completion)
Time frame: at 36 months from start of therapy
Progression-free Survival
Percent of participants still alive and without tumor progression at study completion
Time frame: at 36 months from start of therapy
Freedom From Local Progression
Radiographic efficacy as measured as measured by freedom from local progression (percent of participants without local progression or local recurrence after study completion)
Time frame: at 36 months from start of therapy
Freedom to Distant Recurrence
Radiographic efficacy as measured by distant recurrance (percent of participants without distant failure after study completion)
Time frame: at 36 months from start of therapy
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