Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT00568451
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markovic.svetomir@mayo.edu', 'phone': '507-284-2511', 'title': 'Svetomir N. Markovic M.D., Ph.D.', 'phoneExt': '4-2511', 'organization': 'Mayo Clinic Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This trial was stopped prior to achieving its accrual goals due to slow enrollment rate. Early termination leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TMZ (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Temozolomide (TMZ)', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TMZ (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Temozolomide (TMZ)', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PC (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PC (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 29, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PC (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'OG001', 'title': 'PC (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'OG002', 'title': 'TMZ (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Temozolomide (TMZ)'}, {'id': 'OG003', 'title': 'TMZ (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Temozolomide (TMZ)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment', 'description': 'Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.\n\nCR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response.'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '132'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'comment': 'There is not enough events reported to compute 95% CI upper limit.', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Median', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '4.5', 'statisticalMethod': 'Kaplan-Meier', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'Survival time was defined as the time from registration to death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'timeFrame': 'up to 2 years', 'description': "Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.", 'reportingStatus': 'POSTED', 'populationDescription': 'Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'timeFrame': 'up to 2 years', 'description': 'Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.', 'reportingStatus': 'POSTED', 'populationDescription': 'There is not enough participants to perform this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'timeFrame': 'up to 2 years', 'description': 'For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.', 'reportingStatus': 'POSTED', 'populationDescription': 'There is not enough participants to perform this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'TMZ (Previously Treated) and TMZ (Chemo Naive)'}], 'timeFrame': 'up to 2 years', 'description': 'For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.', 'reportingStatus': 'POSTED', 'populationDescription': 'There is not enough participants to perform this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PC (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'FG001', 'title': 'PC (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'FG002', 'title': 'TMZ (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Temozolomide (TMZ)'}, {'id': 'FG003', 'title': 'TMZ (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Temozolomide (TMZ)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Twelve (12) participants with un-resectable stage IV malignant melanoma were enrolled in the study between June 2006 and November 2008 at Mayo Clinic Rochester.', 'preAssignmentDetails': 'One patient canceled participation in the trial prior to starting Temozolomide therapy. This patient was excluded from all analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PC (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'BG001', 'title': 'PC (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)'}, {'id': 'BG002', 'title': 'TMZ (Previously Treated)', 'description': 'Previously chemotherapy treated cohorts: Temozolomide (TMZ)'}, {'id': 'BG003', 'title': 'TMZ (Chemo Naive)', 'description': 'Chemotherapy-naive cohorts: Temozolomide (TMZ)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '14.85', 'groupId': 'BG002'}, {'value': '63.3', 'spread': '14.05', 'groupId': 'BG003'}, {'value': '62.4', 'spread': '12.97', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'M Stage', 'classes': [{'title': 'M1a (skin/subcutaneous tissue/lymph node only)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'M1b (lung)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'M1c (other visceral sites)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'M stage is based on whether the melanoma has metastasized (spread) to distant organs, which organs it has reached, and on blood levels of a substance called LDH.', 'unitOfMeasure': 'participants'}, {'title': 'Number of Metastatic Sites', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Sites', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Slow accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2007-12-05', 'resultsFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-05', 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria', 'timeFrame': 'Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment', 'description': 'Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.\n\nCR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs.'}], 'secondaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': 'up to 2 years', 'description': 'Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Survival Time', 'timeFrame': 'up to 2 years', 'description': 'Survival time was defined as the time from registration to death due to any cause.'}, {'measure': 'Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response', 'timeFrame': 'up to 2 years', 'description': "Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented."}, {'measure': 'Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment', 'timeFrame': 'up to 2 years', 'description': 'Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.'}, {'measure': 'Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment', 'timeFrame': 'up to 2 years', 'description': 'For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.'}, {'measure': 'Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment', 'timeFrame': 'up to 2 years', 'description': 'For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving paclitaxel together with carboplatin is more effective than giving temozolomide alone in treating patients with melanoma.\n\nPURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with carboplatin or giving temozolomide alone works in treating patients with stage IV melanoma.', 'detailedDescription': 'OBJECTIVES:\n\n* To assess the anti-tumor activity and toxicity profile of timed delivery of conventional paclitaxel and carboplatin (PC) in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.\n* To assess the anti-tumor activity and toxicity profile of timed delivery of conventional temozolomide (TMZ) chemotherapy in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.\n* To assess the anti-tumor activity and toxicity profile of timed delivery of conventional PC in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.\n* To assess the anti-tumor activity and toxicity profile of timed delivery of conventional TMZ chemotherapy in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.\n* To evaluate the changes of T-regulator cells, melanoma-specific functional parameters as a function of time in all four patient cohorts.\n\nOUTLINE: Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no) and scheduled chemotherapy regimen (paclitaxel and carboplatin vs temozolomide).\n\nBeginning at the predicted day of C-reactive peptide (CRP) peak levels, patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15 OR oral temozolomide alone on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo blood sample collection periodically for pharmacological studies. Samples are analyzed for CRP quantification via ELISA; presence and number of circulating blood T-regulator cells via immunophenotyping for CD4/CD25+ and CD4/fox-p3+ T cells; level of functional immunity against melanoma specific antigens (MART-1, tyrosinase, and gp100) and survivin in patients that are HLA-A2+ via intracellular staining; total number of cytotoxic T lymphocytes (CTLs) capable of reacting against melanoma targets via tetramer staining (Becton-Coulter); and quantification of interferon γ-producing, peptide-specific CTLs via multicolor conventional flow cytometry.\n\nAfter completion of study treatment, patients are followed every 3 months for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic melanoma\n\n * Stage IV disease\n * Progressive disease\n * No known standard therapy that is potentially curative or proven capable of extending life expectancy exists\n* Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease\n* Measurable disease as defined by RECIST criteria\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 3 months\n* ANC ≥ 1,500/mL\n* Platelet count ≥ 100,000/mL\n* Hemoglobin ≥ 9 g/dL\n* Creatinine ≤ 2.5 x upper limit of normal (ULN)\n* AST ≤ 3 x ULN\n* Alkaline phosphatase ≤ 3.0 x ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 1 month after completion of study therapy\n* No uncontrolled intercurrent illness including, but not limited to, any of the following:\n\n * Active infection\n * NYHA class III or IV congestive heart failure\n* No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix\n* Willing to provide research blood samples\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Recovered from prior therapy\n* At least 4 weeks since prior radiotherapy\n* At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)\n\n * No prior chemotherapy treatment with agents similar to study drugs\n* No prior chemotherapy in the metastatic setting (for chemo-naive patients)\n* No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used\n* No other concurrent investigational agents\n* No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy'}, 'identificationModule': {'nctId': 'NCT00568451', 'briefTitle': 'Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Releasing the Cancer Patient's Immune System From Down-regulation With Timed Delivery of Standard Chemotherapy", 'orgStudyIdInfo': {'id': 'MC057F'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC057F', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '06-002547', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}, {'id': 'NCI-2010-01794', 'type': 'REGISTRY', 'domain': 'CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PC (previously treated)', 'description': 'Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'PC (chemo naive)', 'description': 'Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)', 'interventionNames': ['Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'TMZ (previously treated)', 'description': 'Previously chemotherapy treated cohorts: Temozolomide (TMZ)', 'interventionNames': ['Drug: temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'TMZ (chemo naive)', 'description': 'Chemotherapy-naive cohorts: Temozolomide (TMZ)', 'interventionNames': ['Drug: temozolomide']}], 'interventions': [{'name': 'carboplatin', 'type': 'DRUG', 'description': 'AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal', 'armGroupLabels': ['PC (chemo naive)', 'PC (previously treated)']}, {'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '100mg/m\\^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal', 'armGroupLabels': ['PC (chemo naive)', 'PC (previously treated)']}, {'name': 'temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar'], 'description': '150mg/m\\^2 at cycle 1, 200mg/m\\^2 at cycle 2 and beyond, orally on days 1-5. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal. One treatment cycle=four weeks', 'armGroupLabels': ['TMZ (chemo naive)', 'TMZ (previously treated)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Svetomir Markovic, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}