Vorinostat and Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Completed · Phase 1/Phase 2

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

In brief

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with bevacizumab and to see how well they work in treating patients with unresectable or metastatic kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 kidney cancer by blocking blood flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.

Key facts

Study ID

NCT00324870

Run by

National Cancer Institute (NCI)

People needed

37

Starts

2006-02-01

Expected to finish

2013-11-01

Last updated by the study team

2016-01-13

Who can join

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

You may qualify if…

• No known CNS metastasis
• ECOG performance status 0-2
• Life expectancy > 6 months
• LVEF ≥ 45%
• Absolute neutrophil count ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST/ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
• PT/INR ≤ 1.5
• Urine protein < 1+ by urinalysis OR < 1 g by 24-hour urine collection
• Not pregnant
• No nursing during and for 6 months after completion of study treatment
• Negative pregnancy test
• Fertile patients must use effective contraception for 2 weeks prior, during, and for 6 months after completion of study treatment
• No other currently active malignancy defined as > 30% risk of relapse upon completion of anticancer therapy, except nonmelanoma skin cancer
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA)
• No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No evidence of bleeding diathesis or coagulopathy
• No active bleeding or pathological conditions that carry high risk of bleeding (i.e., tumor involving major vessels or known varices)
• No ongoing, active infection
• No New York Heart Association class II-IV congestive heart failure
• No angina pectoris requiring nitrate therapy
• No cardiac arrhythmia
• No myocardial infarction within the past 6 months

Where it is running

• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Peninsula Oncology and Hematology PA — Salisbury, Maryland, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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