{
  "FullStudy":{
    "Rank":218286,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510288",
          "OrgStudyIdInfo":{
            "OrgStudyId":"G-0016"
          },
          "Organization":{
            "OrgFullName":"VU University Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Phase 1 Trial of Ipilimumab and GVAX in Patients With Metastatic Castration-resistant Prostate Cancer",
          "OfficialTitle":"A Phase 1 Dose Escalation Trial of Ipilimumab in Combination With CG1940 and CG8711 in Patients With Metastatic Hormone-Refractory Prostate Cancer"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Terminated",
          "WhyStopped":"The study was terminated because Cell Genesys stopped all activities for GVAX.",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2004"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2007",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 4, 2012",
          "StudyFirstSubmitQCDate":"January 10, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 10, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 16, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"A.J.M. van den Eertwegh",
            "ResponsiblePartyInvestigatorTitle":"Dr.",
            "ResponsiblePartyInvestigatorAffiliation":"VU University Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"VU University Medical Center",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Cell Genesys",
                "CollaboratorClass":"INDUSTRY"
              },{
                "CollaboratorName":"Medarex",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this combination have demonstrated potent synergy. The purpose of this study is to investigate, using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic prostate cancer (CRPC) patients.",
          "DetailedDescription":"A promising immunotherapeutic approach in prostate cancer is whole-cell vaccination. Irradiated allogeneic tumor cells expressing GM-CSF generate a long-lasting and specific anti-tumor immunity in preclinical models. Results from several phase I and II trials showed Prostate GVAX (GVAX) to be well tolerated and suggested improved survival. Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) is a crucial immune checkpoint molecule that down-regulates T-cell activation and proliferation. Ipilimumab, a fully human monoclonal antibody (IgG1) that blocks CTLA-4, promotes antitumor immunity, and has been demonstrated in two phase III trials to improve overall survival in metastatic melanoma patients. Pre-clinical studies of the anti-CTLA-4 antibody in combination with GM-CSF secreting tumor cell vaccines demonstrated a potent synergy. In this phase I study the investigators examine in CRPC patients whether ipilimumab can be safely combined with GVAX. In addition, the investigators will treat an additional 16 patients at a dose level of 3•0 mg/kg to determine the safety profile and antitumor effects of GVAX and ipilimumab in patients with CRPC."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Prostate Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "GVAX",
              "Ipilimumab",
              "prostate cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"28",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Ipilimumab and GVAX",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: GVAX and ipilimumab"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"GVAX and ipilimumab",
                "InterventionDescription":"All patients receive a 500 million cell priming dose of granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells (GVAX) intradermally on day 1 followed by bi-weekly intradermal injections of 300 million cells for a 24 week period. The vaccinations are combined with monthly intravenous administrations of ipilimumab. The dose-escalation part of this study will be performed using the standard 3+3 phase-I trial design. Patients will be enrolled in cohorts of three; each cohort will receive an escalating dose of ipilimumab at 0•3, 1•0, 3•0 or 5•0 mg/kg. Sixteen patients will be treated in an expansion cohort with GVAX and 3•0 mg/kg ipilimumab.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Ipilimumab and GVAX"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of patients with adverse events",
                "PrimaryOutcomeTimeFrame":"7 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"number of patients that have a tumor/PSA response",
                "SecondaryOutcomeTimeFrame":"7 months"
              },{
                "SecondaryOutcomeMeasure":"number of patients that will develop a tumor-specific (e.g. PSMA, NY-ESO) antibody response as measured by ELISA",
                "SecondaryOutcomeTimeFrame":"7 months"
              },{
                "SecondaryOutcomeMeasure":"the number of patients that have activated T cells and dendritic cells as measured by FACS",
                "SecondaryOutcomeTimeFrame":"7 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMales age 18-80 years\nHistologic diagnosis of adenocarcinoma of the prostate\nMetastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy\nDetectable metastases by bone scan, CT scan or MRI\nTwo consecutive rising PSA values obtained at least two weeks apart and both obtained at least 4-6 weeks after discontinuation of hormone therapy. Second PSA value must be > 5.0 ng/mL. LHRH agonist should not be discontinued.\nTestosterone < 50 ng/dL. Must have had orchiectomy or is currently receiving an LHRH agonist.\nWBC > 3.0 x 109/L, ANC > 1.5 x 109/L, hemoglobin > 6.2 mmol/L, and platelets > 100 x 109/L\nSerum creatinine < 177 umol/L Bilirubin < 1.5 times the upper limit of normal AST < 3 times the upper limit of normal\nECOG performance status 0-2\nLife expectancy of at least 6 months\nIf sexually active, willing to use barrier contraception during the treatment phase of the protocol\nThe ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\nTransitional cell, small cell, neuroendocrine, or squamous cell prostate cancer\nBone pain severe enough to require routine narcotic analgesia use\nClinical evidence of brain metastases or history of brain metastases\nSeropositive for HIV, Hepatitis B antigen positive and/or Hepatitis C viremic\nPrior chemotherapy or immunotherapy for prostate cancer\nRadiation therapy within 4 weeks of the first treatment\nSurgery within 4 weeks of the first treatment. Must have recovered from all side effects.\nFlutamide within 4 weeks of the first treatment Megesterol acetate (Megace), finasteride (Proscar), bicalutamide (Casodex),nilutamide, aminoglutethimide, ketoconazole or diethylstilbestrol within 6 weeks of the first treatment.\nSystemic corticosteroid use within 4 weeks of the first treatment\nHistory of autoimmune disease\nHistory of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Winald Gerritsen, Prof. MD PhD",
                "OverallOfficialAffiliation":"VU University Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Fons van den Eertwegh, MD PhD",
                "OverallOfficialAffiliation":"VU University Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"VU university medical center",
                "LocationCity":"Amsterdam",
                "LocationZip":"1081 HV",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22326922",
                "ReferenceType":"derived",
                "ReferenceCitation":"van den Eertwegh AJ, Versluis J, van den Berg HP, Santegoets SJ, van Moorselaar RJ, van der Sluis TM, Gall HE, Harding TC, Jooss K, Lowy I, Pinedo HM, Scheper RJ, Stam AG, von Blomberg BM, de Gruijl TD, Hege K, Sacks N, Gerritsen WR. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012 May;13(5):509-17. doi: 10.1016/S1470-2045(12)70007-4. Epub 2012 Feb 10."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000074324",
                "InterventionMeshTerm":"Ipilimumab"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000074322",
                "InterventionAncestorTerm":"Antineoplastic Agents, Immunological"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1348",
                "InterventionBrowseLeafName":"Ipilimumab",
                "InterventionBrowseLeafAsFound":"Ipilimumab",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M1346",
                "InterventionBrowseLeafName":"Antineoplastic Agents, Immunological",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000011471",
                "ConditionMeshTerm":"Prostatic Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005834",
                "ConditionAncestorTerm":"Genital Neoplasms, Male"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000005832",
                "ConditionAncestorTerm":"Genital Diseases, Male"
              },{
                "ConditionAncestorId":"D000011469",
                "ConditionAncestorTerm":"Prostatic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12918",
                "ConditionBrowseLeafName":"Prostatic Neoplasms",
                "ConditionBrowseLeafAsFound":"Prostate Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7529",
                "ConditionBrowseLeafName":"Genital Neoplasms, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7527",
                "ConditionBrowseLeafName":"Genital Diseases, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12916",
                "ConditionBrowseLeafName":"Prostatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}