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The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gencitabine |
|
| 2 | Experimental | Gemcitabine with GI-4000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI-4000 | Biological | Heat-killed yeast cell transfected with target ras mutation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free time and survival | 5 years |
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(A few general items required)
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Tower Cancer Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33786412 | Derived | Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021. |
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| Gemcitabine |
| Drug |
Chemotherapy |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Georgetown University Medical Center / Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Rush University Medical School | Chicago | Illinois | 60612 | United States |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| State University of NY at Stony Brook | Stony Brook | New York | 11794 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Texas Oncology, PA | Dallas | Texas | 75231 | United States |
| The Texas Cancer Center Dallas Southwest | Dallas | Texas | 75237 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| South Texas Oncology & Hematology | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Froedtert Multi-Disciplinary Cancer Clinic | Milwaukee | Wisconsin | 53226 | United States |
| PSG Hospitals | Peelamedu, Coimbatore | Tamil Nadu | 641004 | India |
| Sri Ramchandra Medical College & Research Institute | Ponur, Chennai | Tamil Nadu | 600116 | India |
| Indo American Cancer Hospital and Research Centre | Hyderabad | 500034 | India |
| KMC Hospital | Mangalore | 575001 | India |
| Govt Medical Colleg & Hospital | Nagpur | India |
| Lake Shore Hospital & Research Centre | Nettoor, Cochin | 682304 | India |
| G B Pan Hospital & Maulana Azad Medical College | New Delhi | 110002 | India |
| Nizam's Institute of Medical Sciences | Panjagutta, Hyderaba | 500082 | India |
| Lifeline Multispecialty Hospital | Perungudi, Chennai | 600096 | India |
| Regional Cancer Centre | Trivandrum | 695011 | India |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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