Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Completed · Phase 2

Conditions studied: Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer

In brief

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. 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. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.

Key facts

Study ID

NCT00126490

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2005-03-01

Expected to finish

2013-08-01

Last updated by the study team

2015-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed renal cell cancer
• Metastatic disease
• More than 75% clear cell histology
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No prior refractory disease, defined as clinical or radiologic progression, during or within 3 months after completion of prior interleukin-2 (IL-2)
• Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria:
• Hemoglobin > 10 g/dL (except for patients with hereditary hemoglobinopathy)
• ECOG performance status 0-1 (required)
• Calcium normal (corrected)
• Patients with hypercalcemia due to malignancy allowed provided it has been controlled for > 1 month
• Primary tumor treated or resected by complete nephrectomy, partial nephrectomy, radiofrequency ablation, or other local ablation
• Lactic dehydrogenase < 1.5 times upper limit of normal (ULN)
• No history of or current brain or CNS metastasis by CT scan or MRI within the past 30 days
• Performance status - ECOG 0-1
• More than 4 months
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 75,000/mm\^3
• No history of bleeding diathesis
• PTT < 1.5 times ULN
• INR < 1.5
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• No chronic hepatitis B or C
• Creatinine ≤ 2.0 mg/dL
• No proteinuria* by dipstick urinalysis

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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