NCT01088789Active, not recruitingPhase 2
Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 1 Mar 2010
- Start date
- 20 Apr 2010
- Primary completion date
- 17 Jul 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Pancreatic cancer
- NCT number
- NCT01088789
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 71
- From 20 Apr 2010 to the primary completion date, 17 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.
Other illness
- 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 evidence of active infections.
- 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.
Other
- Has any uncontrolled medical problems.
- Is pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.