Phase 2
N=56
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00389610 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Sep 2022
Primary outcome: Primary: Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity — 1; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GVAX pancreas vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity |
1; 5 | — |
| SECONDARY Overall Survival (OS) |
80.5; 30.7 | — |
| SECONDARY Disease-free Survival (DFS) |
109.5; 13.7 | — |
Summary
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
Eligibility Criteria
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT00389610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.