Kidney Cancer Clinical Trial
Official title:
Dynamic Contrast Enhanced MRI (DCE-MRI) Assessment of the Vascular Changes Induced With Bevacizumab Alone and in Combination With Interferon-α in Patients With Advanced Renal Cell Carcinoma
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.
OBJECTIVES:
Primary
- To establish whether bevacizumab-induced changes in dynamic contrast-enhanced (DCE)-MRI
vascular parameters are significantly enhanced by recombinant interferon alpha-2a.
- To establish whether there is an interferon alpha-2a dose response in potentiating
bevacizumab-induced changes in DCE-MRI vascular parameters.
Secondary
- To correlate changes in DCE-MRI vascular parameters for each treatment group with
progression-free survival.
- To correlate changes in DCE-MRI vascular parameters for each treatment group with tumor
response and changes in tumor size.
- To correlate changes in DCE-MRI vascular parameters for each treatment group with other
surrogate biomarkers.
- To assess the degree of change in baseline K^trans within each arm of treatment.
- To investigate changes in diffusion and blood oxygen-level dependent MRI and their
correlation with other pharmacodynamic endpoints.
- To assess the efficacy and safety profile of bevacizumab monotherapy or in combination
with low or standard doses of recombinant interferon alpha-2a.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks.
- 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.
- Arm III: Patients receive bevacizumab as in arm I and standard-dose recombinant
interferon alpha-2a SC 3 times weekly beginning on day 0.
After 8 weeks of treatment, recombinant interferon alpha-2a dosage may be modified or
discontinued at the discretion of the investigator. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced (gadopentetate dimeglumine) MRI scans at baseline
and weeks 2 and 6. Peripheral blood and serum samples are collected at baseline and weeks 2,
6, and 8 for analysis of surrogate biomarkers by flow cytometry and mRNA analysis by PCR.
Archival histopathological specimens are analyzed by IHC, fluorescence resonance-energy
transfer, and fluorescence lifetime-imaging. Urine samples are also collected at baseline
for proteomic profiling by MALDI-TOF.
After completion of study treatment, patients are followed at 30 days.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic
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