Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-09 @ 1:15 PM
Study NCT ID:
NCT00467051
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562841', 'term': 'Ovarian Germ Cell Cancer'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D018236', 'term': 'Carcinoma, Embryonal'}, {'id': 'D018240', 'term': 'Endodermal Sinus Tumor'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008649', 'term': 'Mesonephroma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Chemotherapy, Biological Therapy)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV dosage 135 mg/m2/dose\n\ncarboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \\[(0.93 x GFR mL/min/m2) + 15\\]= 6.5 x \\[(0.93 x GFR mL/min/m2) + 15\\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.\n\nifosfamide: Given IV dosage 1800 mg/m2/dose\n\nfilgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2\n\nlaboratory biomarker analysis: Optional correlative studies', 'otherNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Nail loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 12}], 'organSystem': 'Investigations'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 9}], 'organSystem': 'Investigations'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 14}], 'organSystem': 'Investigations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Chemotherapy, Biological Therapy)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV dosage 135 mg/m2/dose\n\ncarboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \\[(0.93 x GFR mL/min/m2) + 15\\]= 6.5 x \\[(0.93 x GFR mL/min/m2) + 15\\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.\n\nifosfamide: Given IV dosage 1800 mg/m2/dose\n\nfilgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2\n\nlaboratory biomarker analysis: Optional correlative studies'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)', 'description': 'Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two cycles of chemotherapy; expected to be 42 days of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Chemotherapy, Biological Therapy)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV dosage 135 mg/m2/dose\n\ncarboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \\[(0.93 x GFR mL/min/m2) + 15\\]= 6.5 x \\[(0.93 x GFR mL/min/m2) + 15\\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.\n\nifosfamide: Given IV dosage 1800 mg/m2/dose\n\nfilgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2\n\nlaboratory biomarker analysis: Optional correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Chemotherapy, Biological Therapy)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\npaclitaxel: Given IV dosage 135 mg/m2/dose\n\ncarboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \\[(0.93 x GFR mL/min/m2) + 15\\]= 6.5 x \\[(0.93 x GFR mL/min/m2) + 15\\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2.\n\nifosfamide: Given IV dosage 1800 mg/m2/dose\n\nfilgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2\n\nlaboratory biomarker analysis: Optional correlative studies'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2007-04-25', 'resultsFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2007-04-25', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-11', 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria', 'timeFrame': 'At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)', 'description': 'Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.'}], 'secondaryOutcomes': [{'measure': 'The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.', 'timeFrame': 'Two cycles of chemotherapy; expected to be 42 days of treatment.'}]}, 'conditionsModule': {'conditions': ['Childhood Extracranial Germ Cell Tumor', 'Childhood Extragonadal Malignant Germ Cell Tumor', 'Childhood Malignant Ovarian Germ Cell Tumor', 'Childhood Malignant Testicular Germ Cell Tumor', 'Ovarian Choriocarcinoma', 'Ovarian Embryonal Carcinoma', 'Ovarian Yolk Sac Tumor', 'Recurrent Childhood Malignant Germ Cell Tumor', 'Recurrent Malignant Testicular Germ Cell Tumor', 'Recurrent Ovarian Germ Cell Tumor', 'Testicular Choriocarcinoma', 'Testicular Embryonal Carcinoma', 'Testicular Mixed Choriocarcinoma and Embryonal Carcinoma', 'Testicular Mixed Choriocarcinoma and Yolk Sac Tumor', 'Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor', 'Testicular Yolk Sac Tumor']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT) containing 1 of the following malignant elements:\n\n * Yolk sac tumor (endodermal sinus tumor)\n * Choriocarcinoma\n * Embryonal carcinoma\n* Meets 1 of the following disease criteria:\n\n * Recurrent malignant disease\n * Chemotherapy-resistant disease\n * Relapsed disease\n * Disease refractory to conventional therapy\n* Measurable disease\n* Must have received a prior first-line chemotherapy regimen that included cisplatin\n* Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings alone are not eligible\\*\n* Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or recurrent GCT previously treated with surgery alone are not eligible\n* Karnofsky performance status (PS) 50-100% (age \\> 16 years) OR Lansky PS 50-100% (age ≤ 16 years) OR ECOG PS 0-2\n* Life expectancy ≥ 8 weeks\n* Absolute neutrophil count ≥ 750/mm³\n* Platelet count ≥ 75,000/mm³ (transfusion independent)\n* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal based on age/gender, as defined by the following:\n\n * ≤ 0.4 mg/dL (1 month to \\< 6 months of age)\n * ≤ 0.5 mg/dL (6 months to \\< 1 year of age)\n * ≤ 0.6 mg/dL (1 to \\< 2 years of age)\n * ≤ 0.8 mg/dL (2 to \\< 6 years of age)\n * ≤ 1.0 mg/dL (6 to \\< 10 years of age)\n * ≤ 1.2 mg/dL (10 to \\< 13 years of age)\n * ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)\n * ≤ 1.5 mg/dL (13 to \\< 16 years of age) (male)\n * ≤ 1.7 mg/dL (≥ 16 years of age) (male)\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age\n* ALT \\< 2.5 times ULN for age\n* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated radionuclide study\n* No dyspnea at rest\n* No exercise intolerance\n* Pulse oximetry \\> 94% (if there is clinical indication for determination)\n* Patients with seizure disorder are eligible provided they are on non-enzyme inducing anticonvulsants and seizures are well controlled\n* No CNS toxicity \\> grade 2\n* No active graft-versus-host disease\n* No allergy to Cremophor EL or castor oil\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other concurrent chemotherapy or immunomodulating agents\n* Recovered from prior chemotherapy, immunotherapy, or radiotherapy\n* At least 1 week since prior growth factors (2 weeks for pegfilgrastim)\n* At least 1 week since prior biologic therapy\n* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)\n* At least 2 weeks since prior local palliative radiotherapy (i.e., small port)\n* At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of pelvis\n* At least 6 weeks since other prior substantial bone marrow radiotherapy\n* At least 6 months since prior allogeneic stem cell transplantation\n* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated'}, 'identificationModule': {'nctId': 'NCT00467051', 'briefTitle': 'Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin', 'orgStudyIdInfo': {'id': 'AGCT0521'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00374', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-AGCT0521'}, {'id': 'CDR0000542424'}, {'id': 'AGCT0521', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'AGCT0521', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (chemotherapy, biological therapy)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Biological: Filgrastim', 'Drug: Ifosfamide', 'Other: Laboratory Biomarker Analysis', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemotherapy, biological therapy)']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['FILGRASTIM, LICENSE HOLDER UNSPECIFIED', 'G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tevagrastim'], 'description': 'Given IV or subcutaneously', 'armGroupLabels': ['Treatment (chemotherapy, 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