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Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma

ConditionMalignant Pleural MesotheliomaEstimated Enrollment: 33Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: N16INMStudy First Received: October 24, 2016Last Updated: February 7, 2017Estimated Primary Completion Date: September 2018Primary Outcome Measures:Disease Controle Rate (DCR) at 12 weeks|Safety: the incidence of adverse events, serious adverse events, deaths and laboratory abnormalities.|Disease Controle Rate (DCR) at 6 months|Progression Free Survival (PFS)|Overall Survival (OS)|Overall Response Rate (ORR)Sponsors and Collaborators:The Netherlands Cancer Institute|Bristol-Myers SquibbResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT03048474...

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A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

ConditionMalignant Pleural Mesothelioma (MPM)Estimated Enrollment: 16Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: IRB14-1519Study First Received: January 20, 2016Last Updated: October 13, 2016Estimated Primary Completion Date: February 2018Primary Outcome Measures:Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay|Toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v4.03|Disease control rate defined as the proportion of patients who are assessed as having complete response (CR), partial response (PR), or...

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Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

ConditionRecurrent Malignant Mesothelioma|Stage IA Malignant Mesothelioma|Stage IB Malignant Mesothelioma|Stage II Malignant Mesothelioma|Stage III Malignant Mesothelioma|Stage IV Malignant MesotheliomaEstimated Enrollment: 36Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: MC1023|NCI-2011-03574Study First Received: December 16, 2011Last Updated: August 25, 2016Estimated Primary Completion Date: January 2019Primary Outcome Measures:Adverse event (AE) profile|Describe the safety of the intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma for all cycles out to 90 days.Sponsors and Collaborators:Mayo Clinic|National Cancer Institute (NCI)Result Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT01503177...

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Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

ConditionMesotheliomaEstimated Enrollment: 386Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Participant, Care Provider, Investigator|Primary Purpose: TreatmentStudy ID Numbers: POLARIS2015-003Study First Received: March 5, 2016Last Updated: January 25, 2017Estimated Primary Completion Date: April 2018Primary Outcome Measures:Response Rate|Progression Free SurvivalSponsors and Collaborators:Polaris GroupResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02709512...

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Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma

ConditionMalignant Pleural MesotheliomaEstimated Enrollment: 6Age Group: 18 Years to 75 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: FAPME-1Study First Received: October 31, 2012Last Updated: May 10, 2016Estimated Primary Completion Date: December 2016Primary Outcome Measures:SafetySponsors and Collaborators:University of ZurichResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT01722149...

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Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma

ConditionPleural Epithelioid Mesothelioma|Pleural Malignant MesotheliomaEstimated Enrollment: 10Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: 15-000487|NCI-2015-01736|JCCCID552|P30CA016042Study First Received: November 2, 2015Last Updated: August 8, 2016Estimated Primary Completion Date: January 2018Primary Outcome Measures:Ability to accrue sufficient patients to draw conclusions about endpoints in a timely and expedient manner|Incidence of acute and subacute toxicity defined as grade 4 or 5 adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Incidence of chronic toxicity as assessed by the...

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Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma

ConditionMalignant Pleural MesotheliomaEstimated Enrollment: 54Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: INFLuenCe - MesoStudy First Received: July 17, 2012Last Updated: May 10, 2016Estimated Primary Completion Date: August 2020Primary Outcome Measures:number of participants with adverse events|local cisplatin concentration in the superficial chest wall tissue by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection|safety blood parameters (hematology and clinical chemistry)|overall survival|FFR freedom from recurrence = time to tumor progression by CT or PET-CT/MRI|change from baseline in SF-36 quality of life questionnaire|change from baseline...

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Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent

ConditionRecurrent Pleural Malignant Mesothelioma|Stage IV Pleural MesotheliomaEstimated Enrollment: 55Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 2015-010|NCI-2015-01412|1506014121|P30CA022453Study First Received: October 2, 2015Last Updated: March 28, 2017Estimated Primary Completion Date: January 1, 2018Primary Outcome Measures:Progression-free survival (PFS)|Incidence of grade 3-4 toxicity rate|Overall survival|Response rate (complete and partial response)Sponsors and Collaborators:Barbara Ann Karmanos Cancer Institute|National Cancer Institute (NCI)Result Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02568449...

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Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma

ConditionMesothelioma|BAP1 Loss of FunctionEstimated Enrollment: 67Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: EZH-203Study First Received: July 27, 2016Last Updated: March 23, 2017Estimated Primary Completion Date: September 2018Primary Outcome Measures:Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Cmax|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Tmax|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-t)|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-∞)|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): t1/2|Part 1: Incidence of...

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Nintedanib (BIBF 1120) in Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 537Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double Blind (masked roles unspecified)|Primary Purpose: TreatmentStudy ID Numbers: 1199.93|2012-005201-48Study First Received: July 22, 2013Last Updated: April 18, 2017Estimated Primary Completion Date: October 30, 2019Primary Outcome Measures:Progression free survival measured from the time of randomisation to the time of disease progression or death of any cause, whichever occurs earlier|Overall survival measured from the time of randomisation to the time of death of any cause|Objective response according to modified RECIST analysed by objective response rate|Disease control according to modified RECIST...

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