15 studies in Lung Cancer
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Genetic Epidemiology Of Lung Cancer
Rochester, MN
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Genetic Epidemiology Of Lung Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
The purpose of the study is to compare any inherited or genetic characteristics using blood or tissue specimens collected from individuals who have been diagnosed with lung cancer with the blood or tissue of their family members. The research study is funded by the National Cancer Institute and is part of a national research study being conducted by the Genetic Epidemiology of Lung Cancer Consortium (GELCC).
IRB Number:
07-007338Who can I contact for additional information about this study?
Mariza de Andrade, Ph.D. Principal Investigator Phone: (507) 284-1032 Email: mandrade@mayo.edu
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Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
Scottsdale and Phoenix, AZ
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Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To ascertain whether patients treated by stereotactic body radiation therapy (SBRT) have a 3-year overall survival (OS) rate that is no more than 10% less than patients treated with sublobar resection (SR). Secondary - To compare loco-regional recurrence-free survival between study arms. - To compare disease-free survival between study arms. - To compare grade 3 or higher specific adverse event profiles between study arms at 1, 3, 6, and 12 months post-therapy. - To compare pulmonary function between patients treated with SBRT and patients treated with SR. - To compare the adverse events and pulmonary function tests (PFTs) in each arm for patients with low or high Charlson comorbidity index scores, including a test interaction between Charlson comorbidity index scores (low vs high) and treatment arm. Tertiary - To compare the quality-adjusted survival between the SBRT and SR treatments in terms of time to death (primary) and time until recurrence (secondary). - To examine whether pre-operative and post-operative clinically significant deficits in previously identified prognostic PRO domains (overall quality of life [QOL], fatigue, anxiety, and dyspnea) are associated with shorter patient survival in this patient population and to compare the relative effectiveness of each treatment (SBRT and SR). - To contribute to an ACOSOG bank of normative data in order to improve short/long-term outcomes of cancer patients by identifying patients experiencing clinically significant deficits in patient-reported outcomes and the relationship to genetic variables. - To explore whether blood-based biomarkers, including osteopontins, will be able to predict which patients will be at high risk for recurrence by treatment with either SBRT or SR. (exploratory) - To explore whether blood-based biomarkers, including TGF-β1, will be able to predict which patients will be at high risk for pulmonary complications by treatment with either SBRT or SR. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to planned brachytherapy (yes vs no) and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy* comprising an iodine I 125 implant at the resection margin. - Arm II: Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart. NOTE: *Patients may receive brachytherapy at the discretion of treating physician. Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Tumor tissue samples may also be collected from patients who undergo resection. Patients complete the Lung Cancer Symptom Scale (LCSS), the Linear Analogue Self-Assessment (LASA), and the UCDS Shortness of Breath quality-of-life questionnaires at baseline and periodically during study and follow-up. After completion of study treatment, patients are followed up for 30 days, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
NCT ID:
NCT01336894IRB Number:
11-003256Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Rochester, MN
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Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine symporter (NIS) (MV-NIS [oncolytic measles virus encoding thyroidal sodium iodide symporter])in patients with MPM. SECONDARY OBJECTIVES: Safety and toxicity of the repeated (up to 6 cycles) intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma. TERTIARY OBJECTIVES: I. Time course of viral infection, dissemination and elimination by non-invasive measurements of NIS gene expression using radioactive iodine and single-photon emission computed tomography (SPECT)/ computed tomography (CT) imaging with. II. Viremia, viral replication, and viral shedding following intrapleural administration. III. Changes in humoral and cellular anti-MV immunity following the intrapleural administration of MV-NIS. IV. Antitumor efficacy of this approach by serial measurements of radioiodine uptake by SPECT/CT, radiographic response, and time to disease progression. V. Changes in both local and systemic innate and adaptive anti-tumor immunity following the intrapleural administration of MV-NIS. VI. Effect of MV-NIS administration on the eukaryotic initiation factor (eIF) 4F translation complex in mesothelioma cells. OUTLINE: This is a dose-escalation study. Patients receive the oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intrapleurally. In the absence of unacceptable side effects or disease progression treatment can be repeated every 28 days for up to 6 courses. After completion of study treatment, patients are followed up every 3 to 6 months for up to 5 years.
NCT ID:
NCT01503177IRB Number:
10-002604Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
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Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy
Rochester, MN
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Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin. Secondary - To determine the overall survival of patients treated with this regimen versus observation. - To evaluate the frequency of responses in patients treated with this regimen. - To assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6). - Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.
NCT ID:
NCT01085630IRB Number:
11-007798Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Erlotinib With or Without Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer With EGFR Mutations
Rochester, MN
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Erlotinib With or Without Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer With EGFR Mutations
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine the progression-free survival of erlotinib (erlotinib) and bevacizumab versus that of erlotinib alone for the purpose of deciding if the combination arm is worth pursuing in a phase III trial. SECONDARY OBJECTIVES: I. To investigate the overall survival of erlotinib and bevacizumab versus erlotinib alone. II. To investigate the response rate of erlotinib and bevacizumab versus erlotinib alone. III. To investigate the progression-free survival in patients with exon deletion 19 or exon 21 L858R EGFR point mutations. IV. To investigate the toxicity of erlotinib and bevacizumab versus erlotinib alone using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. TERTIARY OBJECTIVES: I. To correlate EGFR mutations detected in plasma deoxyribonucleic acid (DNA) with those detected in tumor DNA. II. To estimate the prevalence of EGFR T790M resistance mutations from pretreatment tumor biopsies using more sensitive mutation detection methods. III. To investigate progression free survival of EGFR mutant NSCLC patients with and without concurrent EGFR T790M detected from pre-treatment tumor specimen using allele specific quantitative polymerase chain reaction (PCR). IV. To prospectively evaluate the predictive value of plasma vascular endothelial growth factor A (VEGF-A) levels on progression free survival in patients treated with erlotinib alone or in combination with bevacizumab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive erlotinib orally (PO) once daily (QD) on days 1-21. ARM B: Patients receive erlotinib as in Arm A and bevacizumab intravenously (IV) over 30-90 minutes on day 1. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 5 years.
NCT ID:
NCT01532089IRB Number:
11-006881Who can I contact for additional information about this study?
Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
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Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)
Rochester, MN
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Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC. Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions. Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total. The patients will receive the following tests: - Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging - Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background - Follow-up CT every 3 months for 2 years for SBRT groups, with triggers for further evaluation - Baseline CT scan at 3 months for surgery groups, then yearly afterwards - Follow-up Pulmonary Function Tests at 1 year
NCT ID:
NCT01622621IRB Number:
11-000805Who can I contact for additional information about this study?
- Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu
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Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
Rochester, MN
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Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
Mesothelioma is a cancer that develops from serosal surfaces usually in response to prior asbestos exposure. A history of asbestos exposure can be elicited in more than 80% of mesothelioma victims. However, asbestos exposure alone is not sufficient to cause the development of mesothelioma. Nearly 27 million individuals in the US, were exposed to asbestos in the work place between 1940 and 1979 but just 3,000 new cases of mesothelioma are diagnosed each year. Therefore, the investigators hypothesis is that genetic variation in addition to asbestos exposure, and host factors contribute to the development of mesothelioma. It is estimated, based on the investigators preliminary studies, that a population in excess of 1,000 subjects with mesothelioma is required to perform a valid GWAS. Therefore a multicenter approach is necessary to collect data and DNA on sufficient numbers with mesothelioma to adequately evaluate genetic risk. It is the aim of this proposal to develop a consortium of mesothelioma investigators to share phenotypic data and DNA samples and to perform genome wide association scanning (GWAS).
NCT ID:
NCT01590472Who can I contact for additional information about this study?
- Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu
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Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer
Scottsdale and Phoenix, AZ
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Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer
Location:
Scottsdale and Phoenix, AZTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To compare the progression-free survival (PFS) of single-agent linsitinib (OSI-906) to that of single-agent topotecan hydrochloride (topotecan) in patients with relapsed small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To evaluate the response rate (RR), disease-control rate (DCR) and overall survival (OS) of single-agent OSI-906 in patients with relapsed SCLC using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. II. To describe the toxicity profile of single-agent OSI-906 in this population using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. III. To evaluate potential predictive biomarkers of OSI-906 sensitivity by examining multiple biomarkers (molecular and radiographic) and to correlate their pre- and post-treatment samples with clinical outcomes (RR, DCR, PFS, and OS). (Exploratory) IV. To determine whether the baseline IGF-1, IGF-BP's, or angiogenic markers (VEGF and IL-8) plasma levels or their pre- and post-treatment plasma level changes, significantly differ between progressor and non-progressor patients and correlate them with survival. (Exploratory) V. To assess whether the baseline AKT and/or ERK phosphorylation or the extent of inhibition of AKT and/or ERK phosphorylation in peripheral blood mononuclear cells (PBMC) significantly differs between progressors and non-progressors and to correlate them with survival. (Exploratory) VI. To determine whether the subcellular localization of IGF-1R, IGF-BPs, and/or the phosphorylation of IGF-1R throughout the cell by AQUA (automated quantitative immunofluorescence) significantly differs between progressors and non-progressors and correlate them with survival. (Exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to response to prior first-line platinum therapy (platinum sensitive vs platinum resistant) and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive linsitinib orally (PO) twice daily (BID) on days 1-21. Arm II: Patients receive topotecan hydrochloride IV over 30 minutes or PO once daily (QD) on days 1-5.* NOTE: *Patients treated on arm II may crossover to arm I at the time of progressive disease. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline, at 6 weeks of treatment, and at the time of disease progression for IGF-1, IGF-BP's, VEGF, IL-8, Akt, and/or ERK phosphorylation analysis by ELISA and AQUA. Patients undergo enhanced thoracic computed tomography scans at baseline, at 6 weeks of treatment, and at the time of progression for radiomic analysis. After completion of study treatment, patients are followed up for 4 weeks and then every 6 months for 2 years.
NCT ID:
NCT01533181IRB Number:
12-004680Who can I contact for additional information about this study?
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Scottsdale: Helen J. Ross 480-301-8335
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Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Rochester, MN
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Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
Patients will be identified and enrolled from Thoracic Surgical Clinics. A preoperative bronchoscopy will be performed to obtain systematic bronchial biopsies from defined proximal airway sites. Patients will then undergo surgical resection and tumor tissue and normal lung specimens collected. For patients with bronchial dysplasia postoperatively, starting less than 90 days from the time of surgery, patients will be randomized to receive either 850 mg po BID of metformin or observation. Metformin dosing will include a 4 week ramp up of 850 mg po daily prior to starting the BID dose. Adjuvant platinum-based chemotherapy will be applied at the discretion of treating physicians. Patients found to have bronchial dysplasia at the time of bronchoscopy will undergo follow up bronchoscopy and tissue sampling at 6 months follow up.
NCT ID:
NCT01717482IRB Number:
12-006865Who can I contact for additional information about this study?
- Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu
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Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Scottsdale and Phoenix, AZ
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Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Location:
Scottsdale and Phoenix, AZTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy. Secondary - To evaluate the rate of radiographic response to treatment. - To estimate the rates of progression: local/regional/distant. - To estimate the progression-free survival. - To estimate the overall survival. OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy. Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to 5.5 weeks. Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
NCT ID:
NCT01486602Who can I contact for additional information about this study?
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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