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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma

Purpose:

Background:
Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen.
SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells.
Objectives:
To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients’ tumors.
To learn how the body breaks down SS1(dsFV)PE38.
Eligibility:
Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
Design:
Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:
  • Day 1 – Intravenous (through a vein) infusions of pemetrexed and cisplatin.
  • Days 1 and 2 – Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38.
  • Days 1, 3 and 5 – Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined.
Continuing standard treatment with additional cycles of pemetrexed and cisplatin.
Evaluations during the treatment period:
  • Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
  • Questions about medications and side effects.
  • Blood and urine tests.
  • Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires.
Post-treatment evaluations:
  • Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment.
  • End-of-study visit for bl…

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Clinical Trials, Mesothelioma, Status, Terminated
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Amatuximab for High Mesothelin Cancers

Purpose:

Background:
Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
Objectives:
To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.
Eligibility:
Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.
Design:
  • Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
  • Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
  • Participants will have a third imaging study of the cancer about 1 week after the infusions.
  • Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients’ symptoms or side effects. This interview can be done in person or by phone….

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Early Palliative Care With Standard Oncology Care Versus Standard Oncology Care Alone in Advanced Lung and Non-colorectal Gastrointestinal Malignancies

Purpose: The main purpose of this study is to compare two types of care – standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients’ and caregivers’ quality of life, mood, coping and understanding of their illness.

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Purpose:

Background:
  • Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body’s internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for all kinds of mesothelioma, so researchers are searching for new ways to treat it.
  • Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how safe and effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.
Objectives:
To study the safety and effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.
Eligibility:
Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.
Design:
  • Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
  • The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
  • In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
  • On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
  • Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
  • Participants will have regular followup visits as directed by the study doctors….

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Clinical Trials, Closed, Mesothelioma, Status
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Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (NGR019)

Purpose: The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma

Arm A: NGR-hTNF + Best Supportive Care: Experimental
Interventions:
Drug: NGR-hTNF. NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Other: Best Supportive Care. Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
Arm B: Placebo + Best Supportive Care: Placebo Comparator
Interventions:
Drug: Placebo. Placebo: 0.8 mcg/m2 as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Other: Best Supportive Care. Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma

Purpose: The aim of this study is to learn about how mesothelioma affects patients’ emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home.

Surgical group with mesothelioma: Behavioral: Questionnaires & online virtual support group
The study proposed here has two parts:
Part 1 surveys mesothelioma patients’ psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based support group.
In part 2, patients are invited to participate in an Internet-based support group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
Non Surgical group with mesothelioma: Behavioral: Questionnaires & online virtual support group
The study proposed here has two parts:
Part 1 surveys mesothelioma patients’ psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based support group.
In part 2, patients are invited to participate in an Internet-based support group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Autologous Redirected RNA Meso-CIR T Cells

Purpose: To determine the safety and manufacturing feasibility of IV autologous chimeric immune receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor domain and the 4-1BB costimulatory domain.

Cohort 1 – One dose of cells: Experimental
Intervention: Biological: Autologous T cells
Cohort 2 – three doses of cells: Experimental
Intervention: Biological: Autologous T cells

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Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status, Upcoming
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Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)

Purpose: Mesothelioma is a relatively rare cancer which is becoming more common. It can affect one of two areas; the pleura (the lining of the lung) or the peritoneum (the lining of the abdomen). Cancer affecting the pleura is the more common of these and is called Pleural Mesothelioma. This is most commonly caused by exposure to asbestos.

Unfortunately mesothelioma is usually diagnosed at an advanced stage and so treatment is based around controlling the disease and managing the symptoms, rather than curing the disease.

The standard treatment for Advanced Malignant Pleural Mesothelioma is a combination of two anticancer drugs; Pemetrexed and Cisplatin.

The trial will look into whether there are benefits of adding a third drug called Vorinostat to the treatment.

Phase II only – Arm I: Active Comparator
If the patient is randomised into the Vorinostat arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle plus the dose of Vorinostat determined in the phase I study.
Interventions:

  • Drug: Cisplatin.
    Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles
  • Drug: Pemetrexed.
    Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles
  • Drug: Vorinostat.
    The dose and frequency of vorinostat will be determined in the Phase I study. Vorinostat will be given concurrently with Cisplatin/Pemetrexed.
Phase II only – Arm 2: Placebo Comparator
If the patient is randomised into the placebo arm they will be given Pemetrexed (500mg/m2 iv) and Cisplatin (75mg/m2 iv) on day one of a 21 day cycle with the placebo for the same number of days as in the vorinostat arm.
Interventions:

  • Drug: Cisplatin.
    Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles
  • Drug: Pemetrexed.
    Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles
  • Drug: Placebo.
    Patients randomised into the placebo arm of the trial will receive Cisplatin and Pemetrexed as standard as well as placebo.

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Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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Trimodality Therapy for Malignant Pleural Mesothelioma

Purpose: The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons’ decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.

Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.

The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.

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