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Mesotheliona Clinical Trials

In order to one day find a mesothelioma cure, doctors engage in clinical trials where they test new mesothelioma drugs to determine if they are effective.

Mesothelioma clinical trials follow a plan of very strict scientific guidelines, which is called a protocol. The protocol explains everything that will happen in the study. It must be approved by review boards made up of health care professionals and other qualified people before the study can enroll patients.

When a potential mesothelioma drug is first identified, preclinical studies, which are conducted in a laboratory setting, help to find out whether the drug is safe to test in humans. During this stage, the drug is usually studied in animals to answer questions about how a drug works and how the body changes and disposes of it. Humans do not participate in preclinical studies. There are four possible phases of cancer clinical trials in humans, each designed to answer different questions about the treatment being studied.

In Phase I mesothelioma clinical trials, doctors are primarily studying the safety of giving mesothelioma drugs to humans, while also looking for the best way to give a medication (for example, as a pill, an injection, or an infusion). They will usually study how the mesothelioma drug is eliminated from the body in humans. Also, doctors are trying to find the right doses for further testing. They carefully watch for any side effects. Phase I study drugs are usually given to small groups of humans. During this phase, for drugs used to treat mesothelioma cancer, investigators may be able to find out which tumors a treatment works best in.

In Phase II mesothelioma clinical trials, the mesothelioma drug is studied in a larger group. The primary purpose of these studies is to see how well the drug or treatment shrinks tumors in patients with specific types of cancer. The investigator will watch closely for side effects and will also watch how the disease responds to the treatment.

In Phase III mesothelioma clinical trials, the new cancer treatment is generally compared to a standard existing treatment. Patients are usually randomly assigned (that is, a process similar to flipping a coin is used to determine which treatment the patient receives) to receive either a standard treatment or the new treatment. During the trial, patients may or may not be told which treatment they are getting but are told what to expect and what to watch for. Occasionally, even the doctor will not know which treatment each patient is getting so that he or she can remain unbiased about how the disease is responding to the treatment. (This is uncommon in cancer clinical trials). Phase III studies are designed to ensure that any side effects that patients experience are identified and treated according to local standards of care.

Phase IV mesothelioma clinical trials study a drug that has already been approved by the Food and Drug Administration. Drug companies often sponsor these trials to study even more uses of drugs already available.

Note: Information about these below trials are from the ClinicalTrials.gov database:

Rank

Status

Study

Recruiting

Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma

Condition:	Mesothelioma
Intervention:	Behavioral: Questionnaires & online virtual support group
Sponsor:	Memorial Sloan-Kettering Cancer Center
Gender:	Both
Age Groups:	Adult / Senior
Phase:
Number Enrolled:	80
Funded By:	Other
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
NCT Number:	NCT01356251
Other IDs:	11-066
First Received Date:	May 17, 2011
Start Date:	May 2011
Completion Date:	May 2013
Last Updated Date:	September 20, 2011
Last Verified Date:	September 2011
Primary Completion Date:	May 2013
Outcome Measures:	To describe the psychological needs of patients with mesothelioma.; the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma.

Recruiting

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Conditions:	Pleural Mesothelioma; Peritoneal Mesothelioma
Intervention:	Drug: IMC-A12
Sponsor:	National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	55
Funded By:	NIH
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01160458
Other IDs:	100146, 10-C-0146
First Received Date:	July 9, 2010
Start Date:	June 2010
Completion Date:	April 2012
Last Updated Date:	December 29, 2011
Last Verified Date:	March 2011
Primary Completion Date:	April 2012
Outcome Measures:	To determine the clinical response rate (PR+CR) to IMC-A12 monotherapy in patients with advanced mesothelioma.; To determine response duration, progression free survival (PFS) and overall survival (OS).; To assess safety of IMC-A12 in patients with mesothelioma.

Recruiting

Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

Conditions:	Mesothelioma; Pleural Mesothelioma
Interventions:	Drug: Pemetrexed; Drug: Cisplatin
Sponsors:	University Health Network, Toronto; Eli Lilly and Company
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	45
Funded By:	Other / Industry
Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00895648
Other IDs:	05-0815-C
First Received Date:	May 6, 2009
Start Date:	January 2009
Completion Date:	January 2020
Last Updated Date:	March 8, 2010
Last Verified Date:	March 2010
Primary Completion Date:	January 2020
Outcome Measure:	median relapse-free survival (RFS)

Recruiting

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

Condition:	Malignant Mesothelioma
Interventions:	Drug: cediranib maleate; Drug: cisplatin; Drug: pemetrexed disodium; Other: placebo
Sponsors:	Southwest Oncology Group; National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phases:	Phase I / Phase II
Number Enrolled:	116
Funded By:	Other / NIH
Study Type:	Interventional
Study Design:	Allocation: Randomized; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01064648
Other IDs:	CDR0000665415, SWOG-S0905
First Received Date:	February 5, 2010
Start Date:	May 2010
Completion Date:
Last Updated Date:	March 29, 2011
Last Verified Date:	March 2011
Primary Completion Date:	March 2011
Outcome Measures:	Maximum tolerated dose of cediranib maleate (Phase I); Safety and toxicity (Phase I); Progression-free survival (Phase II); Overall survival (Phase II); Response rate (confirmed and unconfirmed, complete and partial responses) (Phase II); Disease control rate (responsive or stable disease) (Phase II); Safety and toxicity profile (Phase II); Rate of agreement between local and central pathology review of mesothelioma and its histologic subtypes (Phase II)

Recruiting

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

Conditions:	Recurrent Malignant Mesothelioma; Stage IA Malignant Mesothelioma; Stage IB Malignant Mesothelioma; Stage II Malignant Mesothelioma; Stage III Malignant Mesothelioma; Stage IV Malignant Mesothelioma
Interventions:	Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter; Other: laboratory biomarker analysis; Procedure: single photon emission computed tomography; Procedure: computed tomography
Sponsors:	Mayo Clinic; National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase I
Number Enrolled:	36
Funded By:	Other / NIH
Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01503177
Other IDs:	MC1023, NCI-2011-03574
First Received Date:	December 16, 2011
Start Date:	November 2011
Completion Date:
Last Updated Date:	January 25, 2012
Last Verified Date:	January 2012
Primary Completion Date:	November 2013
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 23 and/or 90 days.

Recruiting

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Condition:	Mesothelioma
Interventions:	Drug: Pentostatin; Drug: Cyclophosphamide; Drug: SS1P
Sponsor:	National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase I
Number Enrolled:	18
Funded By:	NIH
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01362790
Other IDs:	110160, 11-C-0160
First Received Date:	May 27, 2011
Start Date:	May 2011
Completion Date:	March 2013
Last Updated Date:	December 30, 2011
Last Verified Date:	May 2011
Primary Completion Date:	March 2013
Outcome Measures:	Determining safety, tolerability, and feasibility of a conditioning regimen of pentostatin and cyclophosphamide in combination with SS1(dsFv)PE38; Monitoring antibody formation to SS1(dsFv)PE38 and assessing the impact of the conditioning regimen; To evaluate the objective tumor response, duration of response and progression-free survival; To investigate the potential of soluble mesothelin levels to predict any therapeutic response

Recruiting

Immunotoxin Therapy, Pemetrexed, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed by Surgery

Condition:	Malignant Mesothelioma
Interventions:	Biological: SS1(dsFv)-PE38 immunotoxin; Drug: cisplatin; Drug: pemetrexed disodium; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Other: pharmacological study; Procedure: quality-of-life assessment
Sponsor:	National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase I
Number Enrolled:	24
Funded By:	NIH
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00575770
Other IDs:	080026, CDR0000579640, NCI-08-C-0026, P07188, CAT-5001-1001
First Received Date:	December 15, 2007
Start Date:	June 2007
Completion Date:
Last Updated Date:	September 29, 2011
Last Verified Date:	September 2011
Primary Completion Date:
Outcome Measures:	Maximum-tolerated dose of SS1(dsFv)-PE38 immunotoxin; Pharmacokinetics of SS1(dsFv)-PE38 immunotoxin; Antitumor response; Measurement of antibody formation to drug and impact on pharmacokinetics

Not yet recruiting

A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma

Condition:	Malignant Pleural Mesothelioma
Interventions:	Drug: Cisplatin; Drug: Pemetrexed; Drug: Vorinostat; Drug: Placebo
Sponsors:	University College, London; Merck
Gender:	Both
Age Groups:	Adult / Senior
Phases:	Phase I / Phase II
Number Enrolled:	140
Funded By:	Other / Industry
Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
NCT Number:	NCT01353482
Other IDs:	UCL/08/0359, 2009-013638-26
First Received Date:	May 11, 2011
Start Date:
Completion Date:
Last Updated Date:	May 12, 2011
Last Verified Date:	April 2011
Primary Completion Date:
Outcome Measures:	Phase I only - Dose-limiting toxicities; Phase I only - Number of cycles of pemetrexed-cisplatin given; Phase II only - Progression free survival

Recruiting

Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers

Conditions:	Lung Cancer; Mesothelioma
Intervention:
Sponsor:	University Health Network, Toronto
Gender:	Both
Age Groups:	Adult / Senior
Phase:
Number Enrolled:	1000
Funded By:	Other
Study Type:	Observational
Study Design:	Observational Model: Case Control
NCT Number:	NCT00188890
Other IDs:	Asbestos Screening Study
First Received Date:	September 12, 2005
Start Date:	March 2005
Completion Date:	March 2013
Last Updated Date:	January 19, 2012
Last Verified Date:	January 2012
Primary Completion Date:
Outcome Measure:

Recruiting

Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma

Condition:	Malignant (Pleural) Mesothelioma
Intervention:	Biological: DC + CTX
Sponsor:	Erasmus Medical Center
Gender:	Both
Age Groups:	Child / Adult / Senior
Phase:	Phase I
Number Enrolled:	10
Funded By:	Other
Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01241682
Other IDs:	NL24050.000.08
First Received Date:	June 1, 2010
Start Date:	October 2009
Completion Date:	October 2012
Last Updated Date:	June 22, 2011
Last Verified Date:	June 2011
Primary Completion Date:	October 2011
Outcome Measures:	number of cytotoxic T cells and regulatory T cells in the blood of patients; safety and toxicity

Not yet recruiting

AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma

Condition:	Malignant Mesothelioma
Interventions:	Biological: rilotumumab; Drug: cisplatin; Drug: pemetrexed disodium; Other: laboratory biomarker analysis
Sponsors:	Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	55
Funded By:	Other / NIH
Study Type:	Interventional
Study Design:	Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01105390
Other IDs:	CDR0000670445, ECOG-E1B09
First Received Date:	April 15, 2010
Start Date:	June 2010
Completion Date:
Last Updated Date:	September 3, 2011
Last Verified Date:	April 2010
Primary Completion Date:	October 2012
Outcome Measures:	Progression-free survival; Toxicity; Response rate; Overall survival

Recruiting

Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

Condition:	Malignant Mesothelioma
Interventions:	Drug: cisplatin; Drug: pemetrexed disodium; Other: diagnostic laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery; Radiation: radiation therapy
Sponsor:	Swiss Group for Clinical Cancer Research
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	155
Funded By:	Other
Study Type:	Interventional
Study Design:	Allocation: Randomized; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00334594
Other IDs:	CDR0000481153, SWS-SAKK-17/04, EU-20615, EUDRACT-2006-000445-19, LILLY-SAKK-17/04
First Received Date:	June 7, 2006
Start Date:	November 2005
Completion Date:
Last Updated Date:	September 9, 2011
Last Verified Date:	July 2009
Primary Completion Date:	December 2012
Outcome Measures:	Complete macroscopic resection (part 1); Loco-regional relapse-free survival (part 2); Response to neoadjuvant therapy (part 1); Adverse drug reaction to neoadjuvant therapy (part 1); Operability (part 1); Surgical complications (part 1); Reasons for non-randomization (part 1); Relapse-free or progression-free survival (part 1); Adverse reaction to postoperative radiotherapy (part 2); Late toxicity (part 2); Feasibility of postoperative radiotherapy (part 2); Relapse-free survival (part 2); Psychological distress (quality of life) (part 2); Overall survival

Recruiting

Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy

Condition:	Malignant Mesothelioma
Interventions:	Drug: pemetrexed disodium; Other: clinical observation
Sponsors:	Cancer and Leukemia Group B; National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	96
Funded By:	Other / NIH
Study Type:	Interventional
Study Design:	Allocation: Randomized; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01085630
Other IDs:	CDR0000667496, CALGB-30901
First Received Date:	March 11, 2010
Start Date:	April 2010
Completion Date:
Last Updated Date:	January 28, 2012
Last Verified Date:	January 2012
Primary Completion Date:	January 2012
Outcome Measures:	Progression-free survival; Overall survival; Frequency of responses; Toxicity

Recruiting

Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Condition:	Malignant Mesothelioma
Intervention:	Drug: everolimus
Sponsors:	Southwest Oncology Group; National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	55
Funded By:	Other / NIH
Study Type:	Interventional
Study Design:	Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00770120
Other IDs:	CDR0000616162, SWOG-S0722
First Received Date:	October 8, 2008
Start Date:	December 2008
Completion Date:
Last Updated Date:	April 6, 2011
Last Verified Date:	April 2011
Primary Completion Date:	February 2011
Outcome Measures:	4-month progression-free survival; Response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria; Overall survival; Frequency and severity of toxicities

Recruiting

Axitinib in Malignant Mesothelioma

Condition:	Malignant Pleural Mesothelioma
Interventions:	Biological: axitinib; Drug: chemotherapy
Sponsors:	The Netherlands Cancer Institute; Pfizer
Gender:	Both
Age Groups:	Adult / Senior
Phases:	Phase I / Phase II
Number Enrolled:	20
Funded By:	Other / Industry
Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01211275
Other IDs:	NL25655.031.08
First Received Date:	September 27, 2010
Start Date:	May 2009
Completion Date:	September 2010
Last Updated Date:	September 28, 2010
Last Verified Date:	September 2010
Primary Completion Date:	September 2010
Outcome Measures:	To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples; the side effects of the standard chemotherapy and the additional risks related to axitinib use

Recruiting

A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma

Condition:	Malignant Pleural Mesothelioma
Intervention:	Drug: ADI-PEG 20
Sponsors:	Queen Mary University of London; Cancer Research UK; UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	66
Funded By:	Other
Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT01279967
Other IDs:	6837, 2006-004592-35
First Received Date:	January 19, 2011
Start Date:	January 2011
Completion Date:	January 2014
Last Updated Date:	July 20, 2011
Last Verified Date:	January 2011
Primary Completion Date:	July 2012
Outcome Measures:	progression-free survival; response rate; overall survival; time to progression; safety (adverse events)

Recruiting

Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma

Condition:	Advanced Malignant Pleural Mesothelioma
Interventions:	Drug: NGR-hTNF; Drug: Placebo; Other: Best Supportive Care
Sponsor:	MolMed S.p.A.
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	100
Funded By:	Industry
Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
NCT Number:	NCT01358084
Other IDs:	NGR019, 2010-023614-31
First Received Date:	May 19, 2011
Start Date:	March 2011
Completion Date:	March 2013
Last Updated Date:	December 30, 2011
Last Verified Date:	December 2011
Primary Completion Date:	March 2013
Outcome Measures:	Progression-Free Survival (PFS); Overall survival (OS); Tumor response; Safety and Toxicity according to NCI-CTCAE criteria(version 4.03); Quality of life (QoL) according to Lung Cancer Symptom Scale

Recruiting

Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas

Conditions:	Lung Cancer; Esophageal Cancer; Malignant Pleural Mesothelioma; Thymoma; Thymic Carcinoma
Interventions:	Biological: Allogeneic Tumor Cell Vaccine (K562); Drug: Celecoxib; Drug: cyclophosphamide
Sponsor:	National Cancer Institute (NCI)
Gender:	Both
Age Groups:	Adult / Senior
Phases:	Phase I / Phase II
Number Enrolled:	25
Funded By:	NIH
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
NCT Number:	NCT01143545
Other IDs:	100138, 10-C-0138
First Received Date:	June 11, 2010
Start Date:	May 2010
Completion Date:	May 2017
Last Updated Date:	December 29, 2011
Last Verified Date:	November 2011
Primary Completion Date:	May 2017
Outcome Measures:	To assess the safety of allogeneic K562-GM tumor cell vaccine in combination with metronomic oral cyclophosphamide (CP) and celecoxib in thoracic oncology patients.; To ascertain if K526-GM vaccines induce immunity to CT antigens commonly expressed in thoracic malignancies.; To determine if metronomic oral CP and celecoxib reduce the number, percentage and function of CD4+ CD25+ Fox P3+ regulatory T cells (T reg) in peripheral blood of thoracic oncology patients.

Recruiting

Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma

Condition:	Mesothelioma
Intervention:	Drug: Velcade (bortezomib) plus Eloxatin (oxaliplatin)
Sponsor:	Columbia University
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	29
Funded By:	Other
Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00996385
Other IDs:	AAAD4868
First Received Date:	October 14, 2009
Start Date:	September 2009
Completion Date:	September 2014
Last Updated Date:	October 28, 2011
Last Verified Date:	October 2011
Primary Completion Date:	September 2013
Outcome Measure:	Objective tumor response rate

Recruiting

Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy

Condition:	Mesothelioma
Intervention:	Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Sponsors:	Memorial Sloan-Kettering Cancer Center; Eli Lilly and Company; M.D. Anderson Cancer Center
Gender:	Both
Age Groups:	Adult / Senior
Phase:	Phase II
Number Enrolled:	28
Funded By:	Other / Industry
Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
NCT Number:	NCT00715611
Other IDs:	08-053
First Received Date:	July 11, 2008
Start Date:	July 2008
Completion Date:	July 2012
Last Updated Date:	December 23, 2011
Last Verified Date:	December 2011
Primary Completion Date:	July 2012
Outcome Measures:	To determine the safety of chemotherapy +/- pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of grade 3 or greater pneumonitis.; To determine the response rate, progression free and overall survival rates of patients with malignant pleural mesothelioma treated with chemotherapy, with or without P/D, followed by IMRT to the pleura.; To determine the relationship between response to treatment and the levels of soluble mesothelin-related peptide (SMRP) and osteopontin.; To determine the pattern of progression: local recurrence versus metastatic disease.; To determine the incidence of any grade 3 or greater toxicity.; To determine the association between exhaled NO measurements and radiation pneumonitis