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

NCT00873236 | Unknown Phase 2

• 5 other identifiers: MTVERNHOSP-RD2007-114CDR0000637812ENH-RD2007-114EUDRACT-2008-006414-19EU-20917
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (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)

• 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

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks.

Biological: bevacizumab

Arm II

EXPERIMENTAL

Patients receive bevacizumab as in arm I and low-dose recombinant interferon alpha-2a subcutaneously (SC) 3 times weekly beginning on day 0.

Biological: bevacizumab; Biological: recombinant interferon alpha-2a

Arm III

EXPERIMENTAL

Patients receive bevacizumab as in arm I and standard-dose recombinant interferon alpha-2a SC 3 times weekly beginning on day 0.

Biological: bevacizumab; Biological: recombinant interferon alpha-2a

Interventions

bevacizumab BIOLOGICAL

Given IV

Arm I; Arm II; Arm III

recombinant interferon alpha-2a BIOLOGICAL

Given SC

Arm II; Arm III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mount Vernon Cancer Centre at Mount Vernon Hospital: lead

Study Sites (5)

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

RECRUITING

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

RECRUITING

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Bevacizumab; Interferon alpha-2

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Paul Nathan, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: April 1, 2008
• Last Updated: August 12, 2013

Record last verified: 2009-03

Locations

GB (5)