Nctid:
NCT00001382
Payload:
{"FullStudy"=>{"Rank"=>474275, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000014615", "ConditionMeshTerm"=>"Vaccinia"}, {"ConditionMeshId"=>"D000000230", "ConditionMeshTerm"=>"Adenocarcinoma"}, {"ConditionMeshId"=>"D000011471", "ConditionMeshTerm"=>"Prostatic Neoplasms"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000002277", "ConditionAncestorTerm"=>"Carcinoma"}, {"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000005834", "ConditionAncestorTerm"=>"Genital Neoplasms, Male"}, {"ConditionAncestorId"=>"D000014565", "ConditionAncestorTerm"=>"Urogenital Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000005832", "ConditionAncestorTerm"=>"Genital Diseases, Male"}, {"ConditionAncestorId"=>"D000091662", "ConditionAncestorTerm"=>"Genital Diseases"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000011469", "ConditionAncestorTerm"=>"Prostatic Diseases"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}, {"ConditionAncestorId"=>"D000011213", "ConditionAncestorTerm"=>"Poxviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3275", "ConditionBrowseLeafName"=>"Adenocarcinoma", "ConditionBrowseLeafAsFound"=>"Adenocarcinoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14025", "ConditionBrowseLeafName"=>"Prostatic Neoplasms", "ConditionBrowseLeafAsFound"=>"Prostatic Neoplasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17212", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17053", "ConditionBrowseLeafName"=>"Vaccinia", "ConditionBrowseLeafAsFound"=>"Vaccinia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5224", "ConditionBrowseLeafName"=>"Carcinoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12010", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8636", "ConditionBrowseLeafName"=>"Genital Neoplasms, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17005", "ConditionBrowseLeafName"=>"Urogenital Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2877", "ConditionBrowseLeafName"=>"Genital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8634", "ConditionBrowseLeafName"=>"Genital Diseases, Male", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14023", "ConditionBrowseLeafName"=>"Prostatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26785", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13784", "ConditionBrowseLeafName"=>"Poxviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7132", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M2854", "InterventionBrowseLeafName"=>"Immunomodulating Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17050", "InterventionBrowseLeafName"=>"Vaccines", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"75"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 1994"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2000", "CompletionDateStruct"=>{"CompletionDate"=>"March 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Immunotherapy", "Vaccine"]}, "ConditionList"=>{"Condition"=>["Prostatic Neoplasms"]}}, "DescriptionModule"=>{"BriefSummary"=>"This trial will evaluate, in patients with metastatic prostate cancer, the tolerability, toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC).", "DetailedDescription"=>"This trial will evaluate, in patients with metastatic prostate cancer, the tolerability, toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC). Patients with PSA-expressing adenocarcinoma of the prostate will be evaluated for eligibility that includes a history of prior vaccinia (as vaccine against smallpox) and immunocompetence. We completed a phase I trial investigating the use of rV-CEA in adenocarcinomas of the GI tract, lung and breast. The toxicities encountered are local reactions to the vaccine. We did not encounter any myelosuppression or systemic autoimmune reaction. We would like to evaluate four doses to ensure safety and to decide a best biological dose. Six patients will receive 2.65 x 10(5) PFU and 2.65 x 10(6) PFU of vaccine by scarification. Because higher doses cannot be achieved by scarification, six patients will receive 2.65 x 10(7) PFU and 2.65 x 10(8) PFU subcutaneously. We plan to give three vaccinations at four week intervals. All six patients treated in each dose level must be evaluable for 4 weeks before enrolling patients at the higher dose level. No intrapatient escalation is planned. Toxicity, tumor response, and humoral and cellular immunity factors will be monitored. Optional lymphapheresis will be done on patients that are HLA A2. Once we determined the best biological dose, we would like to accrue an additional 6 patients to that level."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nHistologically confirmed adenocarcinoma of the prostate as follows: Unresectable and/or incurable tumor AND Tumor progression after at least 1 prior hormonal manipulation (i.e., LHRH agonist/flutamide or orchiectomy). LHRH agonist may by continued concurrently with protocol therapy.\n\nNew bone or soft tissue lesions OR Serum PSA that has risen on 3 successive evaluations at least 1 week apart during and/or after hormonal therapy. If PSA is below 4 ng/mL, measurable disease with positive immunohistochemical stain for PSA is required.\n\nNo history of allergy to eggs.\n\nNo history of or active CNS metastases.\n\nSymptomatic spinal or other bony metastasis should be irradiated prior to entry.\n\nBi-dimensionally measurable disease not required.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy:\n\nNo concurrent Biologic Therapy.\n\nMust fully recover from prior Biologic Therapy.\n\nChemotherapy:\n\nAt least 4 weeks since prior chemotherapy and fully recovered.\n\nNo more than 1 prior chemotherapy regimen.\n\nNo concurrent chemotherapy.\n\nEndocrine Therapy:\n\nSee Disease Characteristics.\n\nAt least 4 weeks since prior hormonal therapy and fully recovered.\n\nNo concurrent steroids.\n\nRadiotherapy:\n\nAt least 4 weeks since prior radiation therapy and fully recovered.\n\nNo prior radiotherapy to more than 50% of nodal groups.\n\nNo concurrent radiotherapy.\n\nSurgery:\n\nAt least 4 weeks since prior surgery, with surgical scar healed.\n\nNo prior splenectomy.\n\nPATIENT CHARACTERISTICS:\n\nAge: Over 18.\n\nPerformance status: Zubrod (ECOG) 0-2.\n\nHematopoietic:\n\nAbsolute granulocyte count greater than 2,000/mm(3);\n\nPlatelet count greater than 100,000/mm(3);\n\nHemoglobin greater than 8.0 g/dL.\n\nHepatic:\n\nBilirubin less than 1.6 mg/dL;\n\nAST and ALT less than 4 times normal.\n\nRenal: Creatinine less than 1.6 mg/dL.\n\nImmunologic:\n\nPrior vaccinia (for smallpox immunization) required, with proof of vaccination as follows: Detectable anti-vaccinia antibodies, Physician certification of prior vaccination, Patient recollection or appropriate vaccination-site scar sufficient in patients over age 25, Delayed-type hypersensitivity skin testing (to mumps, Candida, and Trichophyton antigens) normal Quantitative immunoglobulins normal.\n\nNo evidence of immunocompromise, i.e.:\n\nNo HIV antibody;\n\nNo eczema or atopic dermatitis;\n\nNo autoimmune neutropenia, thrombocytopenia, or hemolytic anemia;\n\nNo systemic lupus erythematosus, Sjogren syndrome, or scleroderma;\n\nNo myasthenia gravis;\n\nNo Goodpasture syndrome;\n\nNo Addison's disease, Hashimoto's thyroiditis, or active Graves' disease;\n\nNo other autoimmune disease or diagnosis of altered immune function.\n\nOTHER:\n\nNo active case or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition.\n\nNo active infection requiring antibiotics (including chronic suppressive therapy). At least 3 days since antibiotic therapy.\n\nNo history of seizures, encephalitis, or multiple sclerosis.\n\nNo other serious intercurrent illness.\n\nAble to avoid close contact with the following individuals for at least 2 weeks after vaccination (i.e., no such individuals as household members and no care-giving responsibilities for such individuals): Children under age 3, Pregnant women, Individuals with eczema or skin conditions defined above, Leukemia or lymphoma patients, HIV-positive individuals, Patients receiving immunosuppressive therapy, Any other immunosuppressed individuals.\n\nNo prior malignancy unless curatively treated and patient has been in remission for at least 2 years (excluding squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n\nAble and willing to travel to the NIH, NCI-NMOB, or the Lombardi Cancer Center at Georgetown University for treatment and follow-up."}, "IdentificationModule"=>{"NCTId"=>"NCT00001382", "BriefTitle"=>"A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate", "OrgStudyIdInfo"=>{"OrgStudyId"=>"940118"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"94-C-0118"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"PROSTVAC", "InterventionType"=>"Biological"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}