Dynamic contrast enhanced MRI (DCE-MRI) assessment of the vascular changes induced with bevacizumab alone and in combination with interferon-a in patients with advanced renal cell carcinoma. - DCE-MRI changes in tumour vaculature with Bevacizumab and Interferon in advanced RCC

East and North Hertfordhsire NHS Trust0 sites30 target enrollmentApril 16, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Previously untreated metastatic (stage IV) or locally advanced (inoperable stage III), renal cell carcinoma
Sponsor: East and North Hertfordhsire NHS Trust
Enrollment: 30
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

April 16, 2009

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

East and North Hertfordhsire NHS Trust

•1\. Written informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and consent obtained prior to any study\-specific procedure)
•2\. Male or female subjects \> 18 years
•3\. Patients with previously untreated metastatic (stage IV) or locally advanced (inoperable stage III), renal cell carcinoma
•4\. Subject with histologically and/or cytologically confirmed, advanced (stage IV) RCC, of which a majority component of conventional clear\-cell type is mandatory. Tumours of mixed histology should be categorized by the predominant cell type.
•5\. Good or intermediate prognosis disease as defined by Motzer score.
•6\. RECIST measurable lesion(s), which must be amenable to DCE\-MRI scanning
•7\. Life expectancy of at least 12 weeks
•8\. Eastern Co\-operative Oncology Group (ECOG) performance status 0\-2
•9\. Adequate haematological function:
•10\. Adequate liver function:

•1\. Diagnosis of brain metastasis.
•2\. Major surgery (incl. open biopsy) or radiation therapy within 28 days prior to enrolment (palliative radiotherapy to painful bone lesions is allowed within 14 days prior to enrolment).
•3\. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrolment
•4\. Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, II, or IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment.
•5\. Inadequately controlled hypertension
•6\. History of stroke or transient ischemic attack within 6 months prior to enrolment
•7\. Significant vascular disease (e.g., aortic aneurysm, aortic dissection), or symptomatic peripheral vascular disease
•8\. Evidence or history of recurrent thromboembolism (\>1 episode of DVT/PE) during the past 6 months, bleeding diathesis or coagulopathy
•9\. 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).
•10\. History of abdominal or tracheo\-oesophagel fistula, gastrointestinal perforation, or intra\-abdominal abscess within 6 months prior to study enrolment