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ACTIVE NOT RECRUITING

NCT01088789

PHASE2

Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

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.

Official title: A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene Given Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of Cyclophosphamide for the Treatment of Surgically Resected Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2010-04-20

Completion Date

2026-08

Last Updated

2025-08-26

Healthy Volunteers

Conditions

Pancreatic Cancer

Interventions

DRUG

Cyclophosphamide

Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).

DRUG

Cyclophosphamide Pill

Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).

BIOLOGICAL

GVAX Pancreas Vaccine

Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).

Inclusion Criteria: 1. 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. 2. Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766. 3. 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. 4. 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. 5. Has received the last anti-cancer therapy at least 28 days ago. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Has provided informed consent. 8. Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3). 9. Has adequate renal function (Serum creatinine ≤ 2 mg/dL). 10. 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). 11. Agree to use adequate birth control, if of childbearing potential. Exclusion Criteria: 1. Has radiographic evidence of pancreatic cancer recurrence. 2. Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis. 3. Has any uncontrolled medical problems. 4. Has had systemic steroid therapy within 28 days before vaccine administration. 5. Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration. 6. Has any evidence of active infections. 7. Is pregnant. 8. 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. 9. Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States