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Kidney CancerPhase 2NCT00873236

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

A Phase 2 study testing bevacizumab and recombinant interferon alpha-2a in people with Kidney Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 5 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 bevacizumab alone is more effective than giving bevacizumab together with interferon alpha-2a in detecting kidney cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
bevacizumab and recombinant interferon alpha-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesUnited Kingdom
Study dates
Apr 2008to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites, 5 recruiting
  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

    Contact Person, 44-1223-245-151

    Recruiting
  • Royal Marsden - London

    London, England, SW3 6JJ

    Contact Person, 44-20-7352-8171

    Recruiting
  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

    Paul Nathan, MD, 44-192-384-4966

    Recruiting
  • Churchill Hospital

    Oxford, England, OX3 7LJ

    Contact Person, 44-186-574-1841

    Recruiting
  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

    Contact Person, 44-20-8642-6011

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the 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 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
Kidney Cancer
Being tested
bevacizumab, recombinant interferon alpha-2a
Keywords
stage III renal cell cancer, stage IV renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Given IV

  • recombinant interferon alpha-2aBiological

    Given SC

Study groups in NCT00873236
Study groupRoleWhat they receive
Arm IExperimentalPatients receive bevacizumab IV over 30-90 minutes once every 2 weeks.
Receives: Biological: bevacizumab
Arm IIExperimentalPatients receive bevacizumab as in arm I and low-dose recombinant interferon alpha-2a subcutaneously (SC) 3 times weekly beginning on day 0.
Receives: Biological: bevacizumab; Biological: recombinant interferon alpha-2a
Arm IIIExperimentalPatients receive bevacizumab as in arm I and standard-dose recombinant interferon alpha-2a SC 3 times weekly beginning on day 0.
Receives: Biological: bevacizumab; Biological: recombinant interferon alpha-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Secondary outcomes (13)
  1. Change in vascular permeability (K-trans) and tumor hypoxia at 2 and 6 weeks post-commencement of treatment

  2. Best overall response

  3. Progression-free survival

  4. Time to progression

  5. Treatment duration of bevacizumab and recombinant interferon alpha-2a

  6. Treatment withdrawal

  7. Dose modification

  8. Incidence of adverse events

  9. Number of circulating endothelial cells, circulating endothelial progenitors, and proangiogenic monocytic cells

  10. Angiogenic factors (e.g., VEGF) and hypoxia-regulated markers

  11. Correlation of DCE-MRI defined changes in K-trans with clinical response

  12. Correlation of DCE-MRI defined changes in K-trans with surrogate biomarkers

  13. Analysis of diffusion MRI and blood oxygen-level dependent MRI changes and comparison with other pharmacodynamic markers

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2009 (estimated)
  2. Study startApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00873236
Sponsor's protocol ID
MTVERNHOSP-RD2007-114
Other IDs
CDR0000637812, ENH-RD2007-114, EUDRACT-2008-006414-19, EU-20917
Status last verified
Mar 2009
First submitted
31 Mar 2009
Last updated
12 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and recombinant interferon alpha-2a in people with Kidney Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.

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