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Status:

UNKNOWN

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

Lead Sponsor:

Mount Vernon Cancer Centre at Mount Vernon Hospital

Conditions:

Kidney Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 bevaciz...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00873236

    Start Date

    April 1 2008

    Last Update

    August 12 2013

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ

    2

    Royal Marsden - London

    London, England, United Kingdom, SW3 6JJ

    3

    Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, United Kingdom, HA6 2RN

    4

    Churchill Hospital

    Oxford, England, United Kingdom, OX3 7LJ