Nctid:
NCT00002489
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}], "ancestors"=>[{"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}], "browseLeaves"=>[{"id"=>"M12974", "name"=>"Ovarian Neoplasms", "relevance"=>"LOW"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "relevance"=>"LOW"}, {"id"=>"M16494", "name"=>"Teratoma", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "asFound"=>"Germ cell tumor", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "relevance"=>"LOW"}, {"id"=>"T2475", "name"=>"Germ Cells Tumors", "asFound"=>"Germ cell tumor", "relevance"=>"HIGH"}, {"id"=>"T4355", "name"=>"Ovarian Germ Cell Tumor", "relevance"=>"LOW"}, {"id"=>"T3579", "name"=>"Malignant Germ Cell Tumor", "relevance"=>"LOW"}, {"id"=>"T2163", "name"=>"Extragonadal Germ Cell Tumor", "asFound"=>"Extragonadal germ cell tumor", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002955", "term"=>"Leucovorin"}, {"id"=>"D003609", "term"=>"Dactinomycin"}, {"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D016190", "term"=>"Carboplatin"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D008727", "term"=>"Methotrexate"}, {"id"=>"D005047", "term"=>"Etoposide"}, {"id"=>"D014750", "term"=>"Vincristine"}, {"id"=>"D058766", "term"=>"Levoleucovorin"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000931", "term"=>"Antidotes"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D011500", "term"=>"Protein Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M18650", "name"=>"Carboplatin", "asFound"=>"Followed", "relevance"=>"HIGH"}, {"id"=>"M8191", "name"=>"Etoposide", "asFound"=>"Dietary Supplement", "relevance"=>"HIGH"}, {"id"=>"M1945", "name"=>"Lenograstim", "relevance"=>"LOW"}, {"id"=>"M6191", "name"=>"Leucovorin", "asFound"=>"May", "relevance"=>"HIGH"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M29233", "name"=>"Levoleucovorin", "asFound"=>"Colon", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Serum", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Serum", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Medication", "relevance"=>"HIGH"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M6812", "name"=>"Dactinomycin", "asFound"=>"Intervention Trial", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"Less than", "relevance"=>"HIGH"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M4250", "name"=>"Antidotes", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "asFound"=>"Colon", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-06", "completionDateStruct"=>{"date"=>"2002-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-06-24", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-08-27", "lastUpdatePostDateStruct"=>{"date"=>"2013-06-26", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-08-30", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2002-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage II ovarian germ cell tumor", "stage III ovarian germ cell tumor", "stage IV ovarian germ cell tumor", "ovarian teratoma", "extragonadal germ cell tumor"], "conditions"=>["Extragonadal Germ Cell Tumor", "Ovarian Cancer"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors.", "detailedDescription"=>"OBJECTIVES: I. Determine the efficacy of cyclophosphamide, carboplatin, and etoposide in patients with non-testicular malignant germ cell tumors. II. Improve the quality of life of these patients by shortening the length of treatment and the extent of initial surgical resection. III. Determine whether histologic subtypes have prognostic significance. IV. Determine the efficacy of short term chemotherapy in this patient population. V. Determine the role of second look surgery in predicting curability of non testicular germ cell tumors. VI. Determine the role of dose intensification of cyclophosphamide and the introduction of doxorubicin, methotrexate, and dactinomycin for those patients with partial response, no response, or progressive disease at the time of second look surgery.\n\nOUTLINE: Patients undergo treatment on Regimen A consisting of surgical resection of tumor as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes on day 1, carboplatin IV on day 2, and etoposide IV on days 2-4. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24-48 hours following the last dose of etoposide and continuing for 14 days or until blood counts recover (a total of 28 days). Chemotherapy repeats every 3 weeks for 4 courses in the absence of disease progression. At week 11, patients undergo second look surgery to evaluate response and resect any residual disease. Patients with no residual disease receive no further therapy. Patients with good partial response or no response receive salvage chemotherapy on Regimen B. Patients receive salvage chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3, doxorubicin IV and vincristine IV continuously on days 1-3, and G-CSF SQ daily beginning 24-48 hours following last dose of vincristine and continuing for 14 days or until blood counts recover. At week 3, patients receive cyclophosphamide IV on days 1-2, vincristine IV and doxorubicin IV continuously on days 1-3 and G-CSF as previously given in Regimen B. At week 6, patients receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3 days, beginning 16 hours after the completion of methotrexate. At week 8, salvage chemotherapy repeats for an additional course. Patients achieving complete response following salvage chemotherapy receive no further therapy. Patients with no response are removed from study.\n\nPROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study over 6 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Malignant germ cell tumors of the following stages and primary sites: Stage II/III/IV ovarian tumors Grade II/III immature glial teratomas Stage II/III/IV mediastinal tumors Stage II/III/IV presacral tumors and tumors of other primary sites No intracranial or testicular primary sites\n\nPATIENT CHARACTERISTICS: Age: Child Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified\n\nPRIOR CONCURRENT THERAPY: Not specified"}, "identificationModule"=>{"nctId"=>"NCT00002489", "briefTitle"=>"Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors", "organization"=>{"class"=>"OTHER", "fullName"=>"Memorial Sloan Kettering Cancer Center"}, "officialTitle"=>"PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS", "orgStudyIdInfo"=>{"id"=>"91-119"}, "secondaryIdInfos"=>[{"id"=>"CDR0000077384", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}, {"id"=>"NCI-V92-0021"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"dactinomycin", "type"=>"BIOLOGICAL"}, {"name"=>"filgrastim", "type"=>"BIOLOGICAL"}, {"name"=>"carboplatin", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"etoposide", "type"=>"DRUG"}, {"name"=>"leucovorin calcium", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"vincristine sulfate", "type"=>"DRUG"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Center", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Norma Wollner, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Memorial Sloan Kettering Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Memorial Sloan Kettering Cancer Center", "class"=>"OTHER"}}}}