RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial
Jonsson Comprehensive Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be aged ≥ 18 years at the time of screening * Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations * Life expectancy ≥ 12 months * RCC, diagnosed by radiographic imaging and histology * Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0) * 1-2 solid (\> 80% solid) target lesions * Patient not an ideal candidate for partial nephrectomy or thermal ablati…
Interventions
- ProcedureAngiogram
Undergo angiogram
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- RadiationRadioembolization
Undergo radioembolization
- ProcedureSingle Photon Emission Computed Tomography
Undergo SPECT
- OtherSurvey Administration
Ancillary study
- RadiationYttrium Y 90 Glass Microspheres
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California