A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
- Determine the safety of primary and boost vaccinations with lethally irradiated
allogeneic pancreatic tumor cells transfected with sargramostim (GM-CSF) gene vaccine
in patients with surgically resected adenocarcinoma of the head, neck, or uncinate of
- Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate
stem cell antigen, and mutated k-ras-specific T-cell responses) with clinical response
in patients treated with this regimen.
- Determine the efficacy, in terms of overall and recurrence-free survival, of this
regimen in these patients.
- Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual
boosting in these patients.
- Determine the psychosocial (e.g., demographics, quality of life, hope, trust, social
support, decision control, and advanced directives) and symptom (e.g., pain, anorexia,
fatigue, and mood state) profiles in these patients and explore changes over time.
OUTLINE: This is a open-label study. Patients are stratified according to prior vaccination
with allogeneic sargramostim (GM-CSF)-secreting pancreatic tumor cell vaccine (yes [stratum
I] vs no [stratum II]).
- Stratum I: Patients receive booster vaccination comprising allogeneic GM-CSF plasmid
DNA pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months
in the absence of disease progression or unacceptable toxicity.
- Stratum II: Patients receive priming vaccinations SC once a month for 3 months and then
receive booster vaccinations as in stratum I.
Patients complete self-reported psychosocial (including quality of life, hope, and trust)
and symptom (including pain, fatigue, anorexia, and mood) questionnaires at day 0 and day
After completion of study treatment, patients are followed at day 28 and then annually for
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety as measured by local and systemic toxicities
Patients continue to receive vaccines until disease progression
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|