Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT01088789
This study assesses the safety and feasibility of long-term GVAX Pancreas Vaccine, alone or with cyclophosphamide, in patients with resected pancreatic adenocarcinoma. Eligible participants must have adequate organ function and ECOG status 0-1. Interventions include IV or oral cyclophosphamide and GVAX, administered in specified cycles based on cohort assignment.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene (GVAX Pancreas Vaccine) alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas.
Eligibility Criteria
Inclusion Criteria
- Has a history of surgically resected and pathologically proved AJCC stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas.
- Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766.
- Cohort 2: Have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation.
- Cohorts 1, 3, 4 and 5: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior.
- Has received the last anti-cancer therapy at least 28 days ago.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has provided informed consent.
- Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3).
- Has adequate renal function (Serum creatinine ≤ 2 mg/dL).
- Has adequate hepatic function. (Bilirubin ≤ 2.0 mg/dl, unless known Gilbert's Syndrome; AST, ALT and amylase ≤ 2x upper limit of normal, Alk Phos ≤ 5x upper limit of normal).
- Agree to use adequate birth control, if of childbearing potential.
Exclusion Criteria
- Has radiographic evidence of pancreatic cancer recurrence.
- Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis.
- Has any uncontrolled medical problems.
- Has had systemic steroid therapy within 28 days before vaccine administration.
- Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration.
- Has any evidence of active infections.
- Is pregnant.
- Has a history of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix.
- Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 21205 | Baltimore | Maryland |
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