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
NCT ID: NCT00873236
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks.
bevacizumab
Given IV
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.
bevacizumab
Given IV
recombinant interferon alpha-2a
Given SC
Arm III
Patients receive bevacizumab as in arm I and standard-dose recombinant interferon alpha-2a SC 3 times weekly beginning on day 0.
bevacizumab
Given IV
recombinant interferon alpha-2a
Given SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bevacizumab
Given IV
recombinant interferon alpha-2a
Given SC
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed advanced renal cell carcinoma
* Metastatic (stage IV) disease
* Locally advanced (unresectable stage III) disease
* Previously untreated disease
* Majority component of conventional clear-cell type is mandatory (tumors of mixed histology should be categorized by the predominant cell type)
* Good- or intermediate-prognosis disease as defined by Motzer score
* Lesions measurable by RECIST criteria and amenable to dynamic contrast-enhanced MRI scanning
* No brain metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (may be transfused to maintain or exceed this level)
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN (\< 5 times ULN in patients with liver metastases)
* Serum creatinine ≤ 1.5 times ULN
* Urine dipstick for proteinuria \< 2+ OR \< 1 g of protein in 24-hour urine collection
* INR ≤ 1.5
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use effective contraception during and for 9 months after completion of study treatment
* No significant cardiovascular disease, defined as any of the following, within the past 6 months:
* NYHA class II-IV congestive heart failure
* Unstable angina pectoris
* Myocardial infarction
* No significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vacular disease
* No evidence or history of recurrent thromboembolism (\> 1 episode of deep venous thrombosis/pulmonary embolism) within the past 6 months, bleeding diathesis, or coagulopathy
* No inadequately controlled hypertension (defined as a BP of \> 150 mm Hg systolic and/or \> 100 mm Hg diastolic on medication)
* No history of hypertensive crisis or hypertensive encephalopathy
* No stroke or transient ischemic attack within the past 6 months
* No abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No HIV or hepatitis B or C infection
* No active clinically serious bacterial or fungal infections (\> CTCAE grade 2)
* No other infection \> CTCAE grade 2
* No concurrent active second malignancy within the past 3 years other than nonmelanoma skin cancers or post-treatment for localized prostate cancer
* No gross ascites
* No seizure disorder requiring medication
* No serious non-healing wound, ulcer, or bone fracture
* No contraindications to MRI scanning (e.g., history of claustrophobia or metal fragment implantation)
* No history of allergic reactions to contrast agents
* No other significant medical illness or medically significant abnormal laboratory finding that would, in the investigator's opinion, make the patient inappropriate for this study, or would increase the risk associated with the patient's participation in the study
PRIOR CONCURRENT THERAPY:
* More than 28 days since prior major surgery (including open biopsy) or radiotherapy and recovered
* More than 14 days since prior palliative radiotherapy to painful bone lesions and recovered
* Concurrent palliative radiotherapy for local pain control allowed
* More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
* More than 30 days since prior and no other concurrent investigational agents
* No concurrent chronic daily intake of aspirin ≥ 325 mg/day or clopidogrel \> 75 mg/day, or steroids (prednisone \> 12.5 mg/day or dexamethasone \> 2 mg/day), excluding inhaled steroids
* No concurrent bone marrow transplantation or stem cell rescue
* Concurrent anticoagulation allowed provided INR \< 3 and INR is therapeutic on a stable dose of coumarin-type anticoagulation or if patient is on a stable dose of low molecular weight heparin for \> 2 weeks at the time of enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mount Vernon Cancer Centre at Mount Vernon Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Nathan, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Contact Person
Role: primary
Contact Person
Role: primary
Paul Nathan, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000637812
Identifier Type: REGISTRY
Identifier Source: secondary_id
ENH-RD2007-114
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-006414-19
Identifier Type: -
Identifier Source: secondary_id
EU-20917
Identifier Type: -
Identifier Source: secondary_id
MTVERNHOSP-RD2007-114
Identifier Type: -
Identifier Source: org_study_id