Status:
TERMINATED
PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug that are known to target specific cells (in this case, cells in the immune system) The DC RCC Vaccine is agen...
Detailed Description
This study is divided into 2 groups. The first 22 subjects will be in Group 1 and will receive CT-011 only. The next 22 subjects will be in Group 2 and will receive CT-011 and the DC RCC vaccine. Gro...
Eligibility Criteria
Inclusion
- Stage IV renal cancer
- Measurable disease
- Life expectancy \> 3 months
- Adequate organ and marrow function
Exclusion
- Clinical evidence of central nervous system (CNS) disease. Subjects with a history of treated brain metastasis must be stable with no evidence of disease for 3 months
- Clinically significant autoimmune disease
- HIV+
- Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
- Pregnant or lactating
- History of clinically significant venous thromboembolism (For Cohort 2)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01441765
Start Date
November 1 2011
End Date
July 1 2016
Last Update
February 8 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215