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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma
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NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Purpose: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

Arm A: NGR-hTNF + BIC: Experimental; Intervention: Drug: NGR-hTNF plus Best Investigator Choice (BIC)
Drug: NGR-hTNF plus Best Investigator Choice (BIC)

  • NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
  • Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis

  • Investigator’s Choice: one of the following single-agent chemotherapy might be administered in combination:

    1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
    2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
    3. Vinorelbine: 25-30 mg/m2 iv (or 60-80 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Arm B: Placebo+BIC: Placebo Comparator; Intervention: Drug: Placebo plus Best Investigator Choice (BIC)
Drug: Placebo plus Best Investigator Choice (BIC)

  • Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
  • Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis

  • Investigator’s Choice: one of the following single-agent chemotherapy might be administered in combination:

    1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
    2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
    3. Vinorelbine: 25-30 mg/m2 iv (or 60-80 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)

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

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.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status
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Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

Rationale: Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cediranib maleate 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. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

Purpose: This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and tp see how well it works in treating patients with malignant pleural mesothelioma.

Arm I (phase II): Experimental
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and oral cediranib maleate once daily at the maximum tolerated dose determined in phase I on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral cediranib maleate alone once daily in the absence of disease progression or unacceptable toxicity.
Drug: cediranib maleate, Given orally
Drug: cisplatin, Given IV
Drug: pemetrexed disodium, Given IV
Arm II (phase II): Active Comparator
Patients receive pemetrexed disodium and cisplatin as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive oral placebo alone once daily in the absence of disease progression or unacceptable toxicity.
Drug: cisplatin, Given IV
Drug: pemetrexed disodium, Given IV
Other: placebo, Given orally

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

Purpose: For patients with malignant pleural mesothelioma that has grown despite treatment with standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied. The patients’ physical state, changes in the size of the tumor, and laboratory findings taken during the study will help us decide if everolimus is safe and effective.

Arms: Pts getting everolimus: Experimental
This is a single institution, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.
Drug: everolimus. Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity of toxicity encountered. One cycle will be considered 28 days. Patients will have CT scans to evaluate for response after cycle 1 and cycle 2, and then every two cycles thereafter.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma. (MesoMab)

Purpose: Multicenter, open phase 2 study on patients with malignant mesothelioma. Standardly, 4 to 6 cycles of palliative chemotherapy, platinum in combination with pemetrexed, are given. Despite of this treatment, median survival is poor (9-12 months). By combining conventional cytotoxic agents with a novel agent, hopefully treatment and survival can be approved. Cetuximab or Erbitux is a monoclonal antibody against the EGFR (Epidermal Growth Factor Receptor). By blocking the receptor, it interferes with cel growth and division. Most mesothelioma show a strong expression of the EGFR protein. Apart from that, Cetuximab also has antibody-dependent cell-mediated cytotoxicity (ADCC).

In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be continued until disease progression. Every 6 weeks, a CT scan will be done to evaluate therapy. Most common side effect of Cetuximab is acneiform rash.

The translation research program consists of the determination of EGFR- and K-Ras mutations on the tumor tissue and the correlation with outcome.

In the first part of the trial, 18 patients will be included. After a positive interim analysis, a total of 43 patients will be included.

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma

Purpose: Study chemotherapy will consist of four treatments with Velcade (days 1, 4, 15, and 18) and two treatments with Eloxatin(days 4 and 18). Patients will be undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles (8 weeks). Each patient will be allowed to receive a maximum of 6 cycles of therapy. Following discontinuation of treatment due to disease progression or completion of therapy, patient’s will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Recruiting, Status
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Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

Purpose: Despite the best surgical efforts, complete removal of mesothelioma is possible in approximately 30% of the patients. When surgical removal is complete, chemotherapy followed by radiation therapy is recommended as an effort to improve control over the cancer and survival. This combination of treatments is called TRIMODALITY therapy. Unfortunately, the chances for the tumor coming back after TRIMODALITY therapy remains high. When surgical removal is not complete or not possible, some patients may receive chemo and/or radiation therapy to achieve control over the cancer, but the chances of tumor to growth again remains high and the chances of long term survival remains low.

The combination of Pemetrexed (Alimta) with Cisplatin has been approved as one of the standard chemotherapy drug combinations for the treatment in advanced Malignant Pleural Mesothelioma, and there is likely a group of patients who may benefit and potentially be cured by this therapy. In an effort to achieve a better chance of complete removal of the cancer and long term survival, the investigators are interested in using this drug combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after surgery.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

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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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Recruiting, Status
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Short Neoadjuvant Hemithoracic IMRT for MPM

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.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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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.

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