Clinical trial · Interventional
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
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
NCT00389610CI-TRIAL-00070838completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVAX pancreas vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Previously Vaccinated With GVAX Pancreas Vaccine
- description
- Participants receive booster vaccination every 6 months, given intradermally.
- interventionNames
- Biological: GVAX pancreas vaccine
- type
- EXPERIMENTAL
- label
- GVAX Pancreas Vaccine Naive
- description
- Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
- interventionNames
- Biological: GVAX pancreas vaccine
Primary outcomes (1)
- measure
- Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Inclusion Criteria: A. previously vaccinated subjects must receive Gvax vaccine previously B. naïve and previously vaccinated subjects must meet the following criteria: * have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas * received the last anti-cancer therapy at least 28 days ago. * provide informed consent. * have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm) * have adequate renal function (Serum creatinine ≤ 2 mg/dL). * have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.) * agree to use adequate birth control, if of childbearing potential. 2. Exclusion criteria: * radiographical evidence of pancreatic cancer disease recurrence * documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis * uncontrolled medical problems * systemic steroid therapy within 28 days before vaccine administration * anticipated need for systemic steroid therapy within 28 days after vaccine administration * evidence of active infections * pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.