At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma (RCC), with or without sarcomatoid features.
- ✓Good- or intermediate-risk disease defined by ≤2 of: no prior nephrectomy, Karnofsky <80%, Hgb <12 g/dL, corrected calcium >10.0 mg/dL, or LDH >1.5x ULN.
- ✓Nephrectomy completed ≥28 days prior to enrollment.
- ✓Measurable or evaluable disease by RECIST criteria.
- ✕Non-clear cell RCC histology (papillary, collecting-duct, or chromophobe).
- ✕Prior or concurrent brain or CNS metastases.
- ✕Significant effusions and/or ascites.
- ✕Serious cardiovascular disease including myocardial infarction within 6 months, unstable angina, uncontrolled hypertension (>160/110 mmHg on medication), congestive heart failure, NYHA class III-IV disease, peripheral vascular disease ≥grade II, or arterial thromboembolic events.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
In Brief
A Phase 2 clinical trial evaluating aldesleukin and bevacizumab for Kidney Cancer. Completed, enrolled 26 participants across 1 site.
Detailed Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
Study Details
Timeline
Interventions
SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.