Status:
TERMINATED
Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Renal Cell Cancer
Renal Cell Carcinoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unr...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the appropriate dose of bevacizumab when administered with humanized monoclonal antibody MEDI-522 in patients with unresectable or metastatic renal cell carcinoma pre...
Eligibility Criteria
Inclusion
- Criteria:
- Histologically or cytologically confirmed renal cell carcinoma
- Metastatic or unresectable disease
- Must have received prior sunitinib malate or sorafenib tosylate for metastatic or unresectable disease
- Measurable disease
- No soft tissue disease that has been irradiated within the past 2 months
- More than 6 months since prior and no concurrent treated or untreated brain metastases
- Stable, treated brain metastases allowed provided they remained stable for more than 6 months
- Patients with clinical evidence of brain metastases must have a negative brain CT or MRI scan for metastatic disease
- Zubrod performance status 0-1
- Urine protein:creatinine ratio =\< 0.5 OR urine protein \< 1,000 mg by 24-hour collection
- Not be pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy
- No serious or non-healing wound, ulcer, or bone fracture
- No clinically relevant bleeding diathesis or coagulopathy
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No significant traumatic injury within the past 28 days
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- No New York Heart Association class II-IV congestive heart failure
- No unstable symptomatic arrhythmia requiring medication
- Chronic, controlled arrhythmias (e.g., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- None of the following cardiovascular conditions within the past 6 months: Arterial thrombosis, Unstable angina, Myocardial infarction, Cerebrovascular accident
- Must have controlled blood pressure, defined as systolic blood pressure (BP) =\< 160 mm Hg and/or diastolic BP =\< 90 mm Hg
- More than 7 days since prior core biopsy
- At least 14 days since completion of prior therapy and recovered
- At least 28 days since prior radiotherapy and recovered
- No prior radiotherapy to \>= 25% of bone marrow
- No more than two prior systemic regimens for renal cell carcinoma (including adjuvant treatment)
- No prior bevacizumab or humanized monoclonal antibody MEDI-522
- No major surgical procedure or open biopsy within the past 28 days
- No concurrent need for a major surgical procedure
- Concurrent full-dose anticoagulation with warfarin allowed provided INR is between 2-3
- Concurrent low molecular weight heparin allowed
- No clinically significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00684996
Start Date
June 1 2008
End Date
October 1 2010
Last Update
May 15 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
2
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204