A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas
- Determine overall and disease-free survival of patients with resected stage I or II
adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination
with GVAX pancreatic cancer vaccine.
- Correlate specific in vivo parameters of immune response (post-vaccination delayed-type
hypersensitivity reactions to autologous tumor, mesothelin-specific T-cell response,
and the degree of local eosinophil, macrophage, and T-cell infiltration at the vaccine
site) with clinical responses in patients treated with this regimen.
- Determine the toxic effects associated with intradermal injections of this vaccine in
OUTLINE: This is an open-label study.
- Post surgery vaccination: Within 8-10 weeks after pancreaticoduodenectomy, patients
receive GVAX pancreatic cancer vaccine intradermally (ID) on day 0.
- Adjuvant chemoradiotherapy: Within 16-28 days after the first vaccination, patients
receive fluorouracil (5-FU) IV continuously for 3 weeks. Approximately 1-2 weeks after
completion of 5-FU, patients receive chemoradiotherapy comprising radiotherapy daily
and 5-FU IV continuously for 26-28 weeks. Approximately 3-5 weeks after completion of
chemoradiotherapy, patients receive 5-FU IV continuously for 4 weeks. 5-FU repeats
every 6 weeks for 2 courses.
- Post chemoradiotherapy vaccination: Within 4-8 weeks after the completion of
chemoradiotherapy, patients receive GVAX pancreatic cancer vaccine ID on days 0, 28,
56, and 196.
Treatment continues in the absence of unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
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
Estimate overall survival and disease-free survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines versus chemoradiotherapy alone.
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|