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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01088789
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel Laheru, MD
Principal Investigator Affiliation	Johns Hopkins University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pancreatic Cancer

Arms & Interventions

Arms

Experimental: Cohort 1 (J0810 Arm A)

Patients coming from J0810 (NCT00727441). Patients receive GVAX.

Experimental: Cohort 1 (J0810 Arm B)

Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX.

Experimental: Cohort 1 (J0810 Arm C)

Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX.

Experimental: Cohort 2 (Vaccine Naive)

Patients receive IV CY and GVAX.

Experimental: Cohort 3 (J1568)

Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX.

Experimental: Cohort 4 (J15237)

Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX.

Experimental: Cohort 5 (J1766)

Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX.

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205

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