Status:
COMPLETED
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
Detailed Description
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of RCC with clear cell component
- Measurable disease
- Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
- Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
- At least 28 days since the last chemotherapy
- At least 28 days before the first dose of MDX 1411 since any major surgery
- ECOG performance status 0-2
- No known positivity for human immunodeficiency virus (HIV), Hep B or C
Exclusion
- Previous treatment with any other anti-CD70 antibody
- Active infection requiring i.v systemic therapy within 28 days before first dose
- Evidence of bleeding diathesis or coagulopathy
- Active autoimmune disease requiring immunosuppressive therapy
- Known current drug or alcohol abuse
- Any underlying medical condition which will make the administration of MDX 1411 hazardous
- Psychiatric illness or social situation that would preclude study compliance
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00656734
Start Date
April 1 2008
End Date
June 1 2010
Last Update
May 14 2013
Active Locations (7)
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1
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065