Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: Primary * Determine the safety of pancreatic tumor vaccine, cyclophosphamide, and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas. Secondary * Determine the overall, progression-free, and event-free survival of patients treated with this regimen. * Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen \[PSCA\], mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen. * Correlate downstream targets of epidermal growth factor receptor (EGFR) signaling (e.g., intratumor expression of Akt, Stat 3 and 5, mesothelin, mutated k-ras, and PSCA) with inhibition by cetuximab in patients treated with this regimen. * Correlate inhibition of EGFR signaling (e.g., Stat 3 and 5) with improved specific mesothelin, PSCA, and mutated k-ras-specific T-cell responses in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1, and cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies. At the completion of study treatment, patients are followed at 3 weeks and then every 4 weeks for 16 weeks. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
