Study of a New Vaccine for Kidney Cancer
Author Information
Author(s): Howard L Kaufman, Bret Taback, William Sherman, Dae Won Kim, William H Shingler, Dorota Moroziewicz, Gail DeRaffele, Josephine Mitcham, Miles W Carroll, Richard Harrop, Stuart Naylor, Seunghee Kim-Schulze
Primary Institution: Columbia University
Hypothesis
Can a modified vaccinia virus expressing 5T4 improve the effectiveness of high-dose IL-2 therapy in patients with metastatic renal cell carcinoma?
Conclusion
The vaccine did not improve objective response rates but resulted in stable disease in some patients.
Supporting Evidence
- No serious vaccine-related adverse events were reported.
- 12 patients (48%) had stable disease, which was associated with improved median overall survival.
- All patients developed 5T4-specific antibody responses.
Takeaway
Doctors tested a new vaccine to help patients with kidney cancer, but while it didn't make the cancer go away, some patients stayed stable for longer.
Methodology
25 patients received three immunizations of the vaccine followed by high-dose IL-2 therapy.
Potential Biases
The trial may have been biased by early surgical interventions in some patients.
Limitations
The study was exploratory and lacked formal power calculations; objective responses were not observed by RECIST criteria.
Participant Demographics
Mean age was 58.4 years; 68% male and 32% female; 84% had clear cell carcinoma.
Statistical Information
P-Value
0.0261
Statistical Significance
p = 0.0261
Digital Object Identifier (DOI)
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