Status:
COMPLETED
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Conditions:
Renal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Facto...
Detailed Description
* Patients are being asked to participate if they have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in their body) as a standar...
Eligibility Criteria
Inclusion
- Patients with stage IV renal cancer who have not received prior chemotherapy or biological therapy
- Patients who are to undergo debulking nephrectomy for independent clinical indications or patients with other sites of accessible disease
- Tumor tissue should be at least 2.0cm in longest dimension
- Patients should meet prognostic criteria for intermediate or favorable risk disease as defined by Motzer criteria
- Measurable metastatic disease as defined by a lesion of at least 1cm outside the lesion used for vaccine generation and exclusive of bony metastases
- ECOG Performance Status of 0-2 with greater than six week life expectancy
- 18 years of age or older
- Lab results within range outlined in protocol
Exclusion
- Patients who have received prior chemotherapy
- Clinical evidence of CNS disease. Patients with a history of treated brain metastasis must be stable with no evidence of disease for 3 months
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
- Pregnant of lactating women
- History of clinically significant venous thromboembolism
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00458536
Start Date
October 1 2004
End Date
July 1 2023
Last Update
April 3 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215