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

Johns Hopkins Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Pancreatic Cancer

Treatments: Biological: GVAX Pancreas Vaccine; Drug: Cyclophosphamide; Drug: Cyclophosphamide Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01088789

NA_00031401 (Other Identifier)

J09100

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

71 participants in 7 patient groups

Cohort 1 (J0810 Arm A)

Experimental group

Description:

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

Treatment:

Biological: GVAX Pancreas Vaccine

Cohort 1 (J0810 Arm B)

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Biological: GVAX Pancreas Vaccine

Cohort 1 (J0810 Arm C)

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide Pill

Biological: GVAX Pancreas Vaccine

Cohort 2 (Vaccine Naive)

Experimental group

Description:

Patients receive IV CY and GVAX.

Treatment:

Drug: Cyclophosphamide

Biological: GVAX Pancreas Vaccine

Cohort 3 (J1568)

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Biological: GVAX Pancreas Vaccine

Cohort 4 (J15237)

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Biological: GVAX Pancreas Vaccine

Cohort 5 (J1766)

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Biological: GVAX Pancreas Vaccine