At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive ductal adenocarcinoma of the head, neck, or uncinate process of pancreas
- ✓Stage I or II disease (clinical stage T1-3, N0-1, M0)
- ✓Completely resected (R0) or microscopic residual (R1) disease
- ✓Pancreaticoduodenectomy performed at Johns Hopkins Hospital within past 8-10 weeks
- ✕Tumor histology other than ductal adenocarcinoma (adenosquamous, squamous cell, colloid, islet cell, sarcoma, lymphoma, etc.)
- ✕Recurrent disease
- ✕Metastatic disease, including peritoneal implants, liver, or lung involvement
- ✕Prior or concurrent autoimmune disease requiring systemic immunosuppressants (inflammatory bowel disease, vasculitis, scleroderma, psoriasis, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, etc.)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GVAX pancreatic cancer vaccine for Pancreatic Cancer. Completed, enrolled 60 participants across 1 site.
Detailed Summary
RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas.
Study Details
Timeline
Interventions
Patients will receive vaccinations consisting of 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination.