Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 4:26 PM
Study NCT ID:
NCT02159950
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511774', 'term': 'sipuleucel-T'}, {'id': 'C516109', 'term': 'tasquinimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '716-845-2300', 'title': 'Senior Administrator, Compliance - Clinical Research Services', 'organization': 'Roswell Park Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Due to the study's early closure, as a result of lack of funding, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 57, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 27, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 13, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 24, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Baseline up to 50 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Baseline to up to 3 years', 'description': 'PSA doubling time, PSA slope', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to 3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated and eligible patients.'}, {'type': 'SECONDARY', 'title': 'Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Week 6', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Week 10', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Week 26', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Week 50', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immune Response (Arm 2 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Week 0', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rates (Partial or Complete)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to 3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to 3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to 3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to PSA Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to 3 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Effects of Tasquinimod on the Inhibition of Immune Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'timeFrame': 'Up to week 50', 'reportingStatus': 'POSTED', 'populationDescription': 'Due a Lack of funding data was not collected and no patients were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'FG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV'}, {'id': 'BG001', 'title': 'Arm II (Tasquinimod, Sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nSipuleucel-T: Given IV\n\nTasquinimod: Given PO'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'spread': '.70', 'groupId': 'BG001'}, {'value': '75.4', 'spread': '.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated and eligible patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2014-06-09', 'resultsFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-12', 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effects of Tasquinimod on the Inhibition of Immune Cells', 'timeFrame': 'Up to week 50'}], 'primaryOutcomes': [{'measure': 'Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024', 'timeFrame': 'Baseline up to 50 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in PSA Response', 'timeFrame': 'Baseline to up to 3 years', 'description': 'PSA doubling time, PSA slope'}, {'measure': 'Duration of PSA Response', 'timeFrame': 'Up to 3 years'}, {'measure': 'Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4', 'timeFrame': 'Up to 3 years', 'description': 'The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.'}, {'measure': 'Immune Response', 'timeFrame': 'Week 6'}, {'measure': 'Immune Response', 'timeFrame': 'Week 10'}, {'measure': 'Immune Response', 'timeFrame': 'Week 26'}, {'measure': 'Immune Response', 'timeFrame': 'Week 50'}, {'measure': 'Immune Response (Arm 2 Only)', 'timeFrame': 'Week 0'}, {'measure': 'Objective Response Rates (Partial or Complete)', 'timeFrame': 'Up to 3 years'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 3 years'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Up to 3 years'}, {'measure': 'Time to PSA Progression', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hormone-Resistant Prostate Cancer', 'Metastatic Prostate Carcinoma', 'Recurrent Prostate Carcinoma', 'Stage IV Prostate Cancer']}, 'descriptionModule': {'briefSummary': "This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Tasquinimod may stop the growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sipuleucel-T is more effective with or without tasquinimod in treating prostate cancer.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether tasquinimod augments immune response to sipuleucel-T.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the safety and tolerability of the combination of sipuleucel-T and tasquinimod in patients with castration-resistant metastatic prostate cancer.\n\nII. To obtain preliminary evidence of the clinical benefit of the combination of sipuleucel-T and tasquinimod; to include changes in prostate specific antigen (PSA) over time, and duration of progression-free survival/overall survival.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive sipuleucel-T intravenously (IV) over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive tasquinimod orally (PO) once daily (QD) beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.\n\nAfter completion of study treatment, patients are followed up every 3 months for up to 3 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T\n* Disease progression by PSA criteria (PSA Working Group Consensus Criteria Eligibility) and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Life expectancy \\>= 6 months\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Hemoglobin \\>= 100 g/L (\\>= 10 g/dL)\n* Leukocytes \\>= 3,000/mm\\^3\n* Absolute neutrophil count \\>= 1,500/mm\\^3\n* Platelets \\>= 100,000/mm\\^3\n* Total bilirubin =\\< 1.5 x laboratory upper limit of normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x laboratory upper limit of normal\n* Creatinine =\\< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of \\>= 50 mL/min (please use institutional formula)\n* Prothrombin time (PT)/international normalized ratio (INR) =\\< 1.5\n* Urine protein \\< 1+; if \\>= 1+, 24 hour urine protein should be obtained and should be \\< 1000 mg\n* Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases\n* Ability to understand and the willingness to sign a written informed consent document\n* Patient verbalizes the ability to swallow and retain oral medication\n* Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have received systemic steroids within 4 weeks prior to starting study treatment\n* Patients who have received prior immunotherapies\n* History of therapy for an autoimmune disorder\n* Patients receiving any other investigational agents\n* Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (less than the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months; no uncontrolled hypertension (defined as blood pressure of \\> 160/90 mmHg) on medication or, history of peripheral vascular disease\n* Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4\n* History of psychiatric illness or social situations that would limit compliance with study requirements\n* History of pancreatitis\n* Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible\n* Systemic exposure to ketoconazole or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzyme inhibitors or inducers within 14 days prior to the start of study treatment; systemic exposure to aminodarone is not allowed within 1 year prior to the start of study treatment\n* Ongoing treatment with sensitive cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment\n* Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug"}, 'identificationModule': {'nctId': 'NCT02159950', 'briefTitle': 'Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)', 'orgStudyIdInfo': {'id': 'I 250813'}, 'secondaryIdInfos': [{'id': 'NCI-2014-01184', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 250813', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (sipuleucel-T)', 'description': 'Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Biological: Sipuleucel-T']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (tasquinimod, sipuleucel-T)', 'description': 'Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Biological: Sipuleucel-T', 'Drug: Tasquinimod']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (sipuleucel-T)', 'Arm II (tasquinimod, sipuleucel-T)']}, {'name': 'Sipuleucel-T', 'type': 'BIOLOGICAL', 'otherNames': ['APC8015', 'APC8015 Vaccine', 'PA2024 (PAP/GM-CSF)-Loaded Dendritic Cell Vaccine', 'Provenge'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (sipuleucel-T)', 'Arm II (tasquinimod, sipuleucel-T)']}, {'name': 'Tasquinimod', 'type': 'DRUG', 'otherNames': ['ABR-215050', 'TASQ'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (tasquinimod, sipuleucel-T)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Saby George', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Active Biotech AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}