Phase I/II Trial Evaluating Toxicity and Efficacy of Adding Stereotactic Body Radiotherapy to Sorafenib in Patients With Metastatic, Recurrent, or Unresectable Renal Cell Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Duke University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of Participants With Overall Complete and Partial Response (CR+PR)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety and efficacy of combined stereotactic body radiotherapy (SBRT) + sorafenib in the treatment of patients with Stage IV renal cell carcinoma (RCC) who have recurred locally, developed progression of an unresectable primary or progression of extra-cranial and/or extra-pulmonary metastases while on sorafenib. All subjects will remain on sorafenib during SBRT.
Detailed Description
In the phase I portion of this investigation, subjects will be enrolled in cohorts of three to the SBRT dose groups. Subjects will remain on sorafenib therapy during SBRT. Any change in sorafenib dosage before, during or after SBRT will be at the discretion of the subject's medical oncologist. Subjects will be assessed during, immediately after and at 4 and 8 weeks post-therapy for toxicity. Stereotactic body radiotherapy will be given in increasingly higher dose levels each cohort until the maximum tolerated dose of radiation is determined.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old
- •Zubrod Performance Status 0 or 1
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin \> 9.0 g/dl
- •Absolute neutrophil count (ANC) \> 1,500/mm3
- •Platelet count \> 100,000/mm3
- •Total bilirubin \< 1.5 times institutional upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the institutional ULN
- •Creatinine \< 1.5 times institutional ULN
- •Histologically or cytologically confirmed renal cell carcinoma, which is metastatic, unresectable or recurrent.
Exclusion Criteria
- •Lesion in remaining (solo) kidney
- •Contraindications to radiotherapy or prior radiotherapy overlapping current site(s) of disease.
- •Cardiac disease: Congestive heart failure. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- •Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •Active clinically serious infection
- •Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug.
- •Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.
Outcomes
Primary Outcomes
Number of Participants With Overall Complete and Partial Response (CR+PR)
Time Frame: 8 weeks