Clinical Trials

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management

Purpose: Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.

Arm: Experimental: Indwelling Pleural Catheter
Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.
Device: Indwelling Pleural Catheter
Arm: Active Comparator: Talc Pleurodesis
Hospital admission for chest drain insertion and suction if needed, plus talc pleurodesis by slurry or poudrage if >75% of visceral and parietal pleura in direct contact on chest x-ray.
Procedure: Talc Pleurodesis

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma
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MARS 2: A Feasibility Study Comparing (Extended) Pleurectomy Decortication Versus no Pleurectomy Decortication in Patients With Malignant Pleural Mesothelioma (MARS2)

Purpose: Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2300 people in the UK are diagnosed with mesothelioma each year and the average survival is approximately 17 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 30-40 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) surgery is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to determine if it is feasible to enrol patients with mesothelioma into a study randomising them to chemotherapy only or chemotherapy and lung-sparing surgery. Patients will be followed up regularly at their usual clinic visits for to 5 years. Patients will be asked to complete a Quality of Life Questionnaire at these visits. Tissue samples will be taken at the time of diagnosis and at surgery (if they are randomised to surgery) for mesothelioma research central storage and blood samples will be taken at the clinic visits up to 12 months for mesothelioma research central storage. If we can show the feasibility of recruitment we will apply to continue the study to include more patients in order to determine if lung-sparing surgery improves survival and quality of life for mesothelioma patients.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma

Purpose: This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) for 12 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.

Arms: Experimental: VS-6063 (defactinib)
Administered orally (BID) for 12 days (+/- 2 days)
Assigned Interventions
Drug: VS-6063
Other Name: defactinib

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Clinical Trials, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion (MpeTK01)

Purpose: This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy. Secondary objectives are to evaluate clinical efficacy and biologic activity.

Arms: Experimental: Study Arm
AdV-tk administered intrapleural through pleural catheter followed by oral valacyclovir
Assigned Interventions
Biological: AdV-tk + valacyclovir
Three dose levels of AdV-tk will be evaluated. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
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Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma (SECAR)

Purpose: In vitro studies have demonstrated that sodium selenite in sufficient concentration and during sufficient time have a high tumoricidal capacity. This is found in many human cell types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of cell lines seem to be resistant. The question from a clinical point of view is: Is it possible with respect to toxicity to administer sodium selenite to patients in sufficient dose and during sufficient time to get responses in patients with cancer? We have performed first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during 12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in vitro data suggest that low concentration of continuous exposure for 51 h is much more effective. Now we are planning to continue the phase-I trial with modified protocol.

More specific:

  1. Phase I: Find maximal tolerable dose with continuous infusion
  2. Phase II: Use MTD and study responses, if any
Arms: Experimental: Selenite treatment
In the first part of the study, cohorts of 3 patients receive sodium selenite iv, starting with a dose of 0.5 mg/m2. If no serious adverse event the next cohort is treated according to a dose escalation schedule and this part has been completed. In the modified protocol, a continuous infusion over 2 days will be administered.
Assigned Interventions
Drug: Sodium selenite (Introselen): Intravenous infusion daily for each week day during 2 weeks (10 infusions). After that chemotherapy during 6 weeks. Chemotherapy for each patients is the first line treatment, so chemotherapy differs among patients, with respect to which treatment a patient got as first line. Other Name: Introselen (Pharma Nord)
Drug: Sodium selenite: Intravenous treatment as described above. Cohorts of 3 patient are given a fixed dose for daily treatment (started with 0.5 mg/m2) and if no grade 3 or 4 toxicity, a new cohort is started on a higher dose. The dose for next cohort is 50% higher than for the former cohort. If grade 3 or 4 toxicity is found in 1 patient, 3 more patients are included on the same dose and if one more patient has serious toxicity it is considered to high a dose and a dose in between the toxic dose and the one before is tested. Thus if 2 patients in 3-6 tested patients has serious toxicity by a certain dose, this dose is to high and the highest dose is considered the earlier tested dose. Other Name: Introselen (Pharma Nord)

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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A Dose Escalation Study to Assess Safety of GSK2256098 (FAK Inhibitor) in Combination With Trametinib (MEK Inhibitor) in Subjects With Advanced Solid Tumors

Purpose: The purpose of this study is to assess the safety of combination treatment of GSK2256098 and trametinib in mesothelioma subjects and subjects with other selected tumor types. Also, the study will identify a maximum tolerated combination dose of GSK2256098 and trametinib. This study is a Phase I, open-label, dose-escalation study to determine maximal tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and regimens for oral MEK inhibitor trametinib (once daily [OD]dosing) and the oral FAK inhibitor GSK2256098 (twice daily [BID] dosing). The synergy of the combination was observed over a wide range of concentrations and results in several-fold reduction in compound concentration to achieve equivalent biological responses compared to either single agent. The dose and schedule of dosing may be modified based on emerging safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. The study will be conducted in two parts; Part 1 Dose Escalation to determine the MTD and RP2D and Part 2 Expansion Cohort to further evaluate the safety and tolerability of trametinib and GSK2256098 at the RP2D and determine clinical activity. Additionally, in Part 1 Dose Escalation, additional subjects with malignant pleural mesothelioma (MPM) will be recruited at doses that are considered tolerable in order to assess PD in MPM subjects at each dose (the Pharmacodynamic Cohort). The Expansion Cohort will be limited to subjects with MPM who have progressed or are intolerant to first-line therapy.

Arm: Experimental: Part 1
Part 1 will determine the MTD and RP2D based on the safety and tolerability of GSK2256098 administered with trametinib. Subject will be administered starting dose of 1.0 mg OD trametinib combined with 500 mg BID GSK2256098. Dose escalation will continue until the MTD is established.
Assigned Interventions
Drug: GSK2256098

GSK2256098 250 mg will be supplied as white to off-white, round, biconvex tablets with no markings. GSK2256098 will be administered 30 minutes after a light meal with approximately 240 milliliter of water.

Drug: Trametinib

Trametinib 0.5 mg will be supplied as capsules with no identifying markings. Trametinib will be administered orally under fasting conditions two hours after a meal.

Arm: Experimental: Part 2
Based on determination of combination dose regimen in Part 1, dose expansion cohorts for Part 2 will be opened.
Assigned Interventions
Drug: GSK2256098

GSK2256098 250 mg will be supplied as white to off-white, round, biconvex tablets with no markings. GSK2256098 will be administered 30 minutes after a light meal with approximately 240 milliliter of water.

Drug: Trametinib

Trametinib 0.5 mg will be supplied as capsules with no identifying markings. Trametinib will be administered orally under fasting conditions two hours after a meal.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Purpose: Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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Nintedanib (BIBF 1120) in Mesothelioma

Purpose: This is an exploratory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

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