Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Aduro BioTech, Inc.
ClinicalTrials.gov Identifier:
NCT01417000
First received: August 10, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone in adults who have failed or refused prior treatment for metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: GVAX Pancreas
Biological: CRS-207
Drug: Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Aduro BioTech, Inc.:

Primary Outcome Measures:
  • Overall survival in subjects receiving test treatments [ Time Frame: Up to five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess safety of the cyclophosphamide, GVAX Pancreas vaccine, and CRS-207 treatment regimen [ Time Frame: About 2 years ] [ Designated as safety issue: Yes ]
  • To assess the immune response [ Time Frame: About three years ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
cyclophosphamide (200 mg/m^2) D0 of Weeks 1, 4; GVAX pancreas vaccine (5 x 10e8 cells) D1 of Weeks 1, 4; CRS-207 (1 x 10e9 CFU) Weeks 7, 10, 13, 16
Biological: GVAX Pancreas Biological: CRS-207 Drug: Cyclophosphamide
Other Name: Cytoxan
Experimental: B
cyclophosphamide (200 mg/m^2) D0 of Weeks 1, 4, 7, 10, 13, 16; GVAX pancreas vaccine (5 x 10e8 cells) D1 of Weeks 1, 4, 7, 10, 13, 16
Biological: GVAX Pancreas Drug: Cyclophosphamide
Other Name: Cytoxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required. (Subjects with mixed histology will be included if the predominant component is adenocarcinoma. Subjects must have metastatic disease.)
  • Have received or refused at least one chemotherapy regimen
  • At least 18 years of age
  • ECOG 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:

  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417000

Locations
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Herbert Irving Comprehensive Cancer Center of Columbia University
New York, New York, United States, 10032
NYU Langone Medical Center
New York City, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Aduro BioTech, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Dung T Le, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Aduro BioTech, Inc.
ClinicalTrials.gov Identifier: NCT01417000     History of Changes
Obsolete Identifiers: NCT01468870
Other Study ID Numbers: ADU-CL-01
Study First Received: August 10, 2011
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aduro BioTech, Inc.:
Cancer
Cancer vaccine
Listeria monocytogenes
Listeria-based vaccines
GVAX
Cyclophosphamide
Cytoxan
T regulatory cells
Heterologous Prime-Boost
Immunotherapy
Mesothelin
Pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Cyclophosphamide
Pancreatin
Pancrelipase
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014