Status:
COMPLETED
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
The Skip Viragh Foundation
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
Detailed Description
Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macropha...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 11 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00389610
Start Date
September 11 2006
End Date
December 10 2022
Last Update
October 26 2023
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410