MRI Scans of Blood Vessel Changes Caused by Bevacizumab Alone or Given Together With Interferon Alpha-2a in Treating Patients With Stage III or Stage IV Kidney Cancer

Sponsor
Mount Vernon Cancer Centre at Mount Vernon Hospital
Study ID
NCT00873236
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Given IV
  • recombinant interferon alpha-2a — BIOLOGICAL
    Given SC

Study Details

RATIONALE: Comparing results of MRI scans done after bevacizumab may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether giving bevacizumab alone is more effective than giving bevacizumab together with interferon alpha-2a in detecting kidney cancer. PURPOSE: This randomized phase II trial is studying MRI scans of blood vessel changes caused by bevacizumab to see how well it works compared with bevacizumab given together with interferon alpha-2a in treating patients with stage III or stage IV kidney cancer.

Key Dates

First listed
Apr 1, 2009
Start date
Apr 30, 2008
Status verified
Mar 2009

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm I
    Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks.
  • Experimental: Arm II
    Patients receive bevacizumab as in arm I and low-dose recombinant interferon alpha-2a subcutaneously (SC) 3 times weekly beginning on day 0.
  • Experimental: Arm III
    Patients receive bevacizumab as in arm I and standard-dose recombinant interferon alpha-2a SC 3 times weekly beginning on day 0.

Primary Outcome Measure

Dynamic contrast-enhanced MRI defined changes in K-trans after 6 weeks of bevacizumab monotherapy or bevacizumab and low- or standard-dose recombinant interferon alpha-2a

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