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Cancer Vaccine
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) for Kidney Cancer
Phase 1 & 2
Waitlist Available
Led By David Avigan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing the safety of a new cancer vaccine made from a patient's own tumor cells and dendritic cells (a type of white blood cell). The vaccine will be given with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), which helps the body produce white blood cells. Researchers want to see if the vaccine is safe and causes any side effects.
Eligible Conditions
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF
Secondary outcome measures
To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF
to Correlate Immunologic Response Following Vaccination.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Patients treated with DC/RCC vaccine to evaluate response
Group II: Cohort 1Experimental Treatment2 Interventions
Patients treated with DC/RCC vaccine to evaluate for treatment-limiting toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
2004
Completed Phase 2
~40
Dendritic Cell Tumor Fusion Vaccine
2004
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,234 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,867 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,948 Total Patients Enrolled
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