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
OBJECTIVES:
Primary
- 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.
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
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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival
Continuous
No
Daniel A. Laheru, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
JHOC-J0501, CDR0000463380
NCT00305760
December 2005
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |