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
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|ClinicalTrials.gov Identifier: NCT00873236|
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 1, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Biological: bevacizumab Biological: recombinant interferon alpha-2a||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2008|
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.
Biological: recombinant interferon alpha-2a
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.
Biological: recombinant interferon alpha-2a
- 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
- Change in vascular permeability (K-trans) and tumor hypoxia at 2 and 6 weeks post-commencement of treatment
- Best overall response
- Progression-free survival
- Time to progression
- Treatment duration of bevacizumab and recombinant interferon alpha-2a
- Treatment withdrawal
- Dose modification
- Incidence of adverse events
- Number of circulating endothelial cells, circulating endothelial progenitors, and proangiogenic monocytic cells
- Angiogenic factors (e.g., VEGF) and hypoxia-regulated markers
- Correlation of DCE-MRI defined changes in K-trans with clinical response
- Correlation of DCE-MRI defined changes in K-trans with surrogate biomarkers
- Analysis of diffusion MRI and blood oxygen-level dependent MRI changes and comparison with other pharmacodynamic markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873236
|Cambridge, England, United Kingdom, CB2 2QQ|
|Contact: Contact Person 44-1223-245-151|
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-7352-8171|
|Mount Vernon Cancer Centre at Mount Vernon Hospital||Recruiting|
|Northwood, England, United Kingdom, HA6 2RN|
|Contact: Paul Nathan, MD 44-192-384-4966|
|Oxford, England, United Kingdom, OX3 7LJ|
|Contact: Contact Person 44-186-574-1841|
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Contact Person 44-20-8642-6011|
|Principal Investigator:||Paul Nathan, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|