Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer
NCT01274273 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2014-12-02
Summary
The purpose of this study is to determine whether interleukin-2, interferon-alpha in combination with bevacizumab are effective in the treatment of metastatic renal cell carcinoma (mRCC).
Conditions
- Metastatic Renal Cell Carcinoma
Interventions
- DRUG
-
Interleukin-2
2.4 MIU/m2 s.c. two times daily, 5 days per week, weeks 1 and 2, every 28-day-cycle, for a maximum of 9 cycles (i.e.for a maximum of 9 months).
- DRUG
-
Interferon Alfa-2b
IFN-alfa given as one priming-week of daily IFN 3.0 MIU, followed by up to 9 treatment cycles (i.e. for a maximum of 9 months) with IFN-alfa 3.0 MIU as a fixed dose s.c. once daily - 5 days per week.
- DRUG
-
Bevacizumab doses of 10 mg per kilogram of body weight, given every two weeks i.v. until disease progression, unacceptable toxicity, withdrawal of consent or a maximum of 1 year following obtaining no evidence of disease (NED).
Sponsors & Collaborators
-
Danish Renal Cancer Study Group
collaborator NETWORK -
University of Aarhus
lead OTHER
Principal Investigators
-
Frede Donskov, MD, DMSc · Aarhus University Hospital
-
Poul Geertsen, MD, PhD · University of Copenhagen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- Denmark
Study Locations
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