Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Ether

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Photosensitizing Agents

Patients receive porfimer sodium IV over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative photodynamic therapy to the pleural space.

porfimer sodium

Undergo tumor resection and/or radical pleurectomy

therapeutic conventional surgery

photodynamic therapy

Meng Welliver

This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.

PRIMARY OBJECTIVES; I. To determine the feasibility and toxicities of incorporating surgical resection and intra-operative Photofrin (porfimer sodium)-mediated photodynamic therapy in patients (pts) with malignant pleural mesothelioma (MPM) or non-small cell lung cancer (NSCLC) with pleural spread.

SECONDARY OBJECTIVES:

I. To determine the overall survival rate of pts with NSCLC and pleural spread treated with standard frontline chemotherapy followed by surgical resection and intra-operative Photofrin-mediated photodynamic therapy.

II. To determine the overall survival rate of pts with MPM after radical pleurectomy and intraoperative Photofrin-mediated photodynamic therapy (PDT).

III. To determine the progression-free survival and pleural progression-free survival in the above mentioned pts.

IV. To determine the absolute Photofrin levels in tumor and normal tissues resected from pts using spectrofluorometric assay. Photofrin levels in tumor to normal tissue ratios will be determined.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative PDT to the pleural space.

After completion of treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy

All observed toxicities will be graded, tabled and summarized by frequencies and percentages.

Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Estimated by the method of Kaplan and Meier. PPFS will be estimated for the subset of patients who receive PDT, in order to evaluate the impact of PDT on local control. Survival curves will be plotted. Median and 1-year estimates and confidence intervals will be calculated.

Porfimer sodium concentration in the tissue will be calculated based on the increase in fluorescence resulting from the addition of a known amount of porfimer sodium to each sample after its initial reading. Absolute concentrations of porfimer sodium will also be measured. Distribution of uptake will be summarized by mean, median, standard deviation, range, and histogram. The tumor: normal tissue ratio from direct and indirect measurements will be calculated. Spearman's correlation will be employed to correlate and compare direct and indirect measurements.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Symptoms and General Pathology

Recurrence

Bortezomib

bortezomib

quality-of-life assessment

Dean A. Fennell, MD, PhD

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.

OBJECTIVES:

Primary

* Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.

Secondary

* Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
* Assess safety and toxicity in these patients.
* Assess quality of life using the Lung Cancer Symptom Score.

OUTLINE: This is a multicenter study. Patients are stratified according to current treatment (first-line vs second-line)

Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients exhibiting objective response or stable disease by week 20, may continue treatment at the discretion of the investigator until evidence of disease progression.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed for up to 2 years.

PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.

Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma

The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.

Quality of life will be assessed using the Lung Cancer Symptom Score

Cancer Trials Ireland

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

everolimus

Sai-Hong I. Ou, MD, PhD

Linda Garland, MD

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with pleural malignant mesothelioma that cannot be removed by surgery.

OBJECTIVES:

Primary

* To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.

Secondary

* To determine the 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.
* To determine overall survival of these patients.
* To evaluate the frequency and severity of toxicities associated with this treatment regimen.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 3 years.

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a \>= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease

A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a \>= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.

Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Daily oral Everolimus 10 mg/day

everolimus

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Epithelial

Mesothelioma, NOS

Biphasic

Not Reported

Histology

None

Single

Multiple

Number of Metastatic Sites

1 Regimen

2 Regimens

Prior Systemic Regimens

0: Fully active, able to carry on all pre-disease performance without restriction.

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.

Performance Status

< 5%

5% - < 10%

10% - 20%

Weight Loss Last 6 Months

Number of patients who were eligible and received treatment and thus analyzable.

Lung Committee Statistician

Progression-Free Survival

Response

Overall Survival

Anorexia

Confusion

Dehydration

Diarrhea

Dyspnea (shortness of breath)

Fatigue (asthenia, lethargy, malaise)

Glucose, serum-high (hyperglycemia)

Hemoglobin

INR (of prothrombin time)

Inf (clin/microbio) w/Gr 3-4 neuts - Lung

Infection with unknown ANC - Lung (pneumonia)

Left ventricular systolic dysfunction

Lymphopenia

Mucositis/stomatitis (clinical exam) - Oral cavity

Mucositis/stomatitis (functional/symp) - Oral cav

Muscle weakness, not d/t neuropathy - body/general

Pneumonitis/pulmonary infiltrates

Rash/desquamation

Triglyceride, serum-high (hypertriglyceridemia)

Number of Subjects With Greater Than Grade 2 Toxicity

Frequency and Severity of Toxicities

Overall Study

Infections

Virus Diseases

Measles

Micronutrients

Iodine

Patients receive MV-NIS intrapleurally on day 1. Treatment repeats every 28 days for up to 6 courses in absence of disease progression or unacceptable toxicity.

oncolytic measles virus encoding thyroidal sodium iodide symporter

laboratory biomarker analysis

single photon emission computed tomography

computed tomography

Tobias Peikert

This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells

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.

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma

The number and severity of toxicity incidents will indicate the level of tolerance for MV-NIS in the therapy of MPM. Non-hematologic toxicities will be evaluated via the CTCAE v4.0 standard toxicity grading. Hematologic toxicity measures such as anemia, neutropenia and thrombocytopenia will be assessed using continuous variables as the outcome measures (nadir and percent change from baseline values) as well as categorization via CTCAE v4.0 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

The number and severity of adverse events (AE) over the course of up to 6 cycles of MV-NIS therapy will indicate the level of tolerance for MV-NIS in the therapy of MPM. AE will be evaluated similar to the primary outcome via the CTCAE v4.0 standard toxicity grading and frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

Mayo Clinic

Neoplasm Metastasis

Pleural Effusion, Malignant

Pleural Effusion

Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.

Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

talc

therapeutic thoracoscopy

therapeutic videothoracoscopy

Robert Winter, MD

RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

OBJECTIVES:

Primary

* Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.

Secondary

* Compare the control of pleural effusion in these patients.
* Compare procedure-related complications in these patients.
* Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
* Compare the length of hospital stay for these patients.
* Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
* Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.

* Arm I (video-assisted thoracoscopic \[VAT\] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
* Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.

Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

Papworth Hospital NHS Foundation Trust

Sorafenib

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

sorafenib tosylate

Pasi Janne

This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PRIMARY OBJECTIVES:

I. To determine the response rate (partial response (PR) and complete response (CR)) in patients with malignant mesothelioma treated with BAY 43-9006.

SECONDARY OBJECTIVES:

I. To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006.

II. To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006.

III. To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma.

IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006.

V. To determine whether the amount of expression of phospho-ERK1/2, as determined by immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma.

VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.

A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma

The frequency of best response to the new treatment will be tabulated and the exact 95% binomial confidence intervals will be computed.

Disease Progression

Hematinics

Vitamins

Pemetrexed

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

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.

Patients undergo observation until disease progression.

pemetrexed disodium

clinical observation

Arkadiusz Dudek, MD

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.

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.

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test

The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.

Alliance for Clinical Trials in Oncology

Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy	NCT02106559	Stage III Malig... Stage IIIB Non-... Stage IV Malign... Stage IV Non-sm...	porfimer sodium therapeutic con... photodynamic th...	18 Years -	Ohio State University Comprehensive Cancer Center
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma	NCT00513877	Malignant Mesot...	bortezomib quality-of-life...	18 Years -	Cancer Trials Ireland
S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery	NCT00770120	Malignant Mesot...	everolimus	18 Years - 120 Years	SWOG Cancer Research Network
Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma	NCT01503177	Recurrent Malig... Stage IA Malign... Stage IB Malign... Stage II Malign... Stage III Malig... Stage IV Malign...	oncolytic measl... laboratory biom... single photon e... computed tomogr...	18 Years -	Mayo Clinic
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma	NCT00821860	Malignant Mesot... Metastatic Canc...	talc therapeutic tho... therapeutic vid...	18 Years -	Papworth Hospital NHS Foundation Trust
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma	NCT00513877	Malignant Mesot...	bortezomib quality-of-life...	18 Years -	Cancer Trials Ireland
Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.	NCT00107432	Epithelial Meso... Recurrent Malig... Sarcomatous Mes... Stage IA Malign... Stage IB Malign... Stage II Malign... Stage III Malig... Stage IV Malign...	sorafenib tosyl... laboratory biom...	18 Years -	National Cancer Institute (NCI)
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy	NCT01085630	Malignant Mesot...	pemetrexed diso... clinical observ...	18 Years -	Alliance for Clinical Trials in Oncology
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy	NCT02106559	Stage III Malig... Stage IIIB Non-... Stage IV Malign... Stage IV Non-sm...	porfimer sodium therapeutic con... photodynamic th...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage iv malignant mesothelioma