A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux (Cetuximab) for the Treatment of Advanced Pancreatic Adenocarcinoma
- Determine the safety of sargramostim plasmid DNA pancreatic tumor cell vaccine,
cyclophosphamide, and cetuximab in patients with metastatic or locally advanced
adenocarcinoma of the pancreas.
- 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
OUTLINE: This is an open-label study.
Patients receive cyclophosphamide IV on day 0, sargramostim plasmid DNA pancreatic tumor
cell 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
Patients undergo blood collection and tumor biopsies periodically during study for biomarker
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Daniel A. Laheru, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|