At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
- ✓Measurable disease ≥20 mm on conventional imaging or ≥10 mm on spiral CT
- ✓ECOG performance status 0-1
- ✓Adequate bone marrow function: ANC ≥1,500/μL, platelets ≥100,000/μL, hemoglobin >9.0 g/dL
- ✕Prior systemic anticancer therapy for RCC; prior radiotherapy for RCC within 4 weeks
- ✕Brain metastases, leptomeningeal disease, primary brain tumor, or uncontrolled seizure disorder
- ✕Active acute infections
- ✕Significant cardiovascular disease: MI within past year, NYHA Grade II+ CHF, uncontrolled dysrhythmia, or Grade II+ peripheral vascular disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib Tosylate, Recombinant Interferon Alfa-2b, and 1 other intervention for Clear Cell Renal Cell Carcinoma and 2 related conditions. Completed, enrolled 80 participants across 1 site.
Detailed Summary
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
Study Details
Timeline
Interventions
Given orally 400 mg orally (PO) every 12 hours
Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10\^6 international units twice daily
Correlative studies