Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
The Skip Viragh Foundation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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.
Clareo Health | Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
