Purpose: Malignant pleural mesotheliomas (MPMs) are tumours associated with asbestos exposure involving the tissue lining surrounding the lung. Radiation therapy (RT) dramatically reduces the risk of tumour recurrence within the irradiated area (>90%). But patients continue to succumb to MPMs due to the tumour spreading outside the chest cavity. This may be due to tumour cells inadvertently contaminating areas outside the chest cavity during surgery. The study will look at whether giving a short intense course of chest radiation just prior to surgery will sterilized these tumour cells and thus, avoid or reduce contamination of the areas outside the chest cavity. The investigators hypothesize that short neoadjuvant (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce the incidence of distant metastatic disease.
Mesothelioma
Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery
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.
Efficacy Study of MORAb-009 in Subjects With Pleural Mesothelioma
Purpose: This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Optical Coherence Tomography of the Airway in Detecting Abnormal Cells in Patients Undergoing Surgery for Lung Cancer or Lung Disease
Rationale: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.
Purpose: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.
Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy
Purpose: For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy +/-pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma.
- Arm I: Experimental
- This is a single institution phase II toxicity study of chemotherapy +/- Pleurectomy/Decortication (P/D) followed by Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Patients will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2 ) or carboplatin (AUC=5) every 3 weeks. After completion of the chemotherapy, patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will have this performed and four to six weeks later they will be treated with IMRT, 50.4 Gy in 28 fractions. If patients have unresectable disease, they will be treated with IMRT, 50.4 Gy in 28 fractions after completion of the chemotherapy.
Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II)
Purpose: The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial.
The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
- Arm A: Experimental. Drug: pemetrexed, cisplatin and CBP501
- CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
- Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
- Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
- Arm B: Active Comparator. Drug: pemetrexed and cisplatin
- Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
- Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
ChemoFx® PRO – A Post-Market Data Collection Study
Purpose: This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)
Purpose: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
- Arm 1: Standard Chemotherapy
- Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
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- Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
- Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
- Arm 2: Standard Chemotherapy + bevacizumab (Avastin)
- Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
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- Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
- Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
- Bevacizumab 15 mg/kg D1 (D1=D22, until progression)
Dasatinib in Resectable Malignant Pleural Mesothelioma
- Primary Objectives:
- The primary objective of this novel phase I trial will be the level of biomarker modulation of p-Src Tyr 419 by induction dasatinib therapy in patients with resectable malignant pleural mesothelioma.
- Secondary Objectives:
- Secondary objectives include overall and progression-free survival, tumor radiographic and pathologic response, and safety-toxicity profiles. Exploratory analyses will include additional biomarker evaluation in pre- and post-treatment tumor specimens, and serum/platelet/pleural effusion biomarker modulation.
- Arms: Dasatinib: Experimental
- 70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy (NAC-PNP)
Purpose: In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lung cancer with chemotherapy containing cisplatin.
- Arm 1: Active Comparator
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- Drug: N-Acetylcysteine.
- Intervention:
N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg. - Other Name: Fluimucil
- Arm 2: Placebo Comparator
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- Drug: Placebo.
- Intervention: Placebo once every 3 weeks intravenous saline fluid.
- Other Name: Placebo
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