Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer

Sponsor
University of Aarhus
Study ID
NCT01274273
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interleukin-2 — DRUG
    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).
  • Interferon Alfa-2b — DRUG
    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.
  • Bevacizumab — 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).

Study Details

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).

Key Dates

First listed
Jan 11, 2011
Start date
Oct 31, 2009
Status verified
Aug 2012
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interleukin-2, interferon, bevacizumab
  • Active Comparator: Interleukin-2 and interferon-alfa

Primary Outcome Measure

Progression free survival, PFS [ Time Frame: This is defined as the time between date of randomisation and the first date of documented disease progression or date of death due to any cause. ]

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