This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.
PRIMARY OBJECTIVE: I. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria. II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C. V. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire. OUTLINE: Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Undergo angiogram
Undergo blood sample collection
Undergo CT scan
Undergo radioembolization
Undergo SPECT
Ancillary study
Given intra-arterially
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGNumber of treatment related adverse events
Time frame: Up to 2 years
Number of serious adverse events
Time frame: Up to 2 years
Overall response rate (ORR)
According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson.
Time frame: Up to 2 years
Duration of response
According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology.
Time frame: From the first response and first observation of progressive disease, up to 2 years
Renal time to progression
According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.
Time frame: Up to 2 years
Progression free-survival
According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.
Time frame: Up to 2 years
Overall survival
Kaplan Meier curves will be presented.
Time frame: Up to 2 years
Change in renal function
Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C.
Time frame: Up to 2 years
Proportion of patients receiving subsequent treatment for RCC after study treatment
Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.
Time frame: Up to 2 years
Type of subsequent RCC treatment received after study treatment
Will be summarized using descriptive summaries.
Time frame: Up to 2 years
Proportion of patients to undergo curative therapy
Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.
Time frame: Up to 2 years
Time to subsequent RCC treatment (local or systemic therapy)
Will be summarized using descriptive summaries.
Time frame: Up to 2 years
Correlation between tumoral absorbed dose, with efficacy and safety
Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)
Time frame: Up to 2 years
Correlation between normal tissue absorbed dose, with efficacy and safety
Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)
Time frame: Up to 2 years
Change in Eastern Cooperative Oncology Group score
The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome.
Time frame: Up to 2 years
Change in quality of life as measured by the SF-36 (QualityMetrics) Quality of Life survey
Change in overall quality of life based on patient-reported outcomes
Time frame: Up to 2 years
Percentage of subjects with absorbed Y90 dose within range (+/- 20%) of planned dose
Time frame: Up to 2 years
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