Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
NCT ID: NCT01417000
Last Updated: 2018-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2011-09-21
2017-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cy/GVAX + CRS-207
200 mg per square meter (mg/m\^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units \[CFU\]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
GVAX Pancreas
CRS-207
Cyclophosphamide
Cy/GVAX
200 mg/m\^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.
GVAX Pancreas
Cyclophosphamide
Interventions
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GVAX Pancreas
CRS-207
Cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have received or refused at least one chemotherapy regimen
* At least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Anticipated life expectancy of \>12 weeks
* For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects \[male and female\], regardless of other methods.)
* Be willing and able to give written informed consent, and be able to comply with all study procedures
* Have adequate organ function as defined by specified laboratory values
Exclusion Criteria
* Known history or evidence of brain metastases
* Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
* Have clinically significant and/or malignant pleural effusion
* Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or CRS-207, or known allergy to both penicillin and sulfa
* Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
* Used any systemic steroids within 28 days of study treatment
* Use more than 3 g/d of acetaminophen
* Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
* Infection with HIV or hepatitis B or C at screening
* Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
* Be pregnant or breastfeeding
* Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Aduro Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dung T Le, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center of Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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Brockstedt DG, Giedlin MA, Leong ML, Bahjat KS, Gao Y, Luckett W, Liu W, Cook DN, Portnoy DA, Dubensky TW Jr. Listeria-based cancer vaccines that segregate immunogenicity from toxicity. Proc Natl Acad Sci U S A. 2004 Sep 21;101(38):13832-7. doi: 10.1073/pnas.0406035101. Epub 2004 Sep 13.
Laheru D, Lutz E, Burke J, Biedrzycki B, Solt S, Onners B, Tartakovsky I, Nemunaitis J, Le D, Sugar E, Hege K, Jaffee E. Allogeneic granulocyte macrophage colony-stimulating factor-secreting tumor immunotherapy alone or in sequence with cyclophosphamide for metastatic pancreatic cancer: a pilot study of safety, feasibility, and immune activation. Clin Cancer Res. 2008 Mar 1;14(5):1455-63. doi: 10.1158/1078-0432.CCR-07-0371.
Le DT, Dubenksy TW Jr, Brockstedt DG. Clinical development of Listeria monocytogenes-based immunotherapies. Semin Oncol. 2012 Jun;39(3):311-22. doi: 10.1053/j.seminoncol.2012.02.008.
Le DT, Wang-Gillam A, Picozzi V, Greten TF, Crocenzi T, Springett G, Morse M, Zeh H, Cohen D, Fine RL, Onners B, Uram JN, Laheru DA, Lutz ER, Solt S, Murphy AL, Skoble J, Lemmens E, Grous J, Dubensky T Jr, Brockstedt DG, Jaffee EM. Safety and survival with GVAX pancreas prime and Listeria Monocytogenes-expressing mesothelin (CRS-207) boost vaccines for metastatic pancreatic cancer. J Clin Oncol. 2015 Apr 20;33(12):1325-33. doi: 10.1200/JCO.2014.57.4244. Epub 2015 Jan 12.
Related Links
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For more information, please click here to visit Aduro's website.
Other Identifiers
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ADU-CL-01
Identifier Type: -
Identifier Source: org_study_id
NCT01468870
Identifier Type: -
Identifier Source: nct_alias
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