Purpose: The primary objective of the study is to determine the overall 1 year survival rate of the two combined arms.

Arm A: Intrapleural chemotherapy plus systemic chemotherapy

Drug: Doxorubicin and cisplatin (intrapleural) + cisplatin and pemetrexed (systemic)

Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.

Arm B: Intrapleural chemotherapy

Drug: Cisplatin and doxorubicin (intrapleural)

Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.

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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.

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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.

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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.

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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)

• 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

• 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)

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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.

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