Mesothelioma

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
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A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Purpose This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.

Arms: Experimental: Amatuximab infusion
Assigned Interventions

  • Drug: Amatuximab: Subjects will receive one low dose (50mg) infusion of amatuximab followed by an infusion of radiolabeled amatuximab.
  • Other Names:
    • MORAb-009
    • MORAB-009-006

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Clinical Trials, Closed, Mesothelioma, Mesothelioma of the Tunica Vaginalis, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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BAY 94-9343 for Advanced Solid Tumors

Purpose:

Background:
Mesothelin is a protein on the lining of the lungs, heart, and abdomen. It is often present at higher levels on some cancer cells. Anticancer drugs given directly to cells with high mesothelin levels may help destroy the cancer cells with fewer effects on healthy cells. BAY 94-9343 combines an anticancer drug with a type of protein that targets mesothelin. Researchers want to see if BAY 94-9343 can treat advanced cancers that have mesothelin on the cells.
Objectives:
To test the safety and effectiveness of BAY 94-9343 on advanced solid tumors.
Eligibility:
Individuals at least 18 years of age who have advanced solid tumors that have mesothelin on the cells.
Design:
  • Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and imaging studies. Heart and lung function tests and an eye exam will also be included.
  • The study drug will be given in 3-week cycles of treatment. At the start of each cycle, participants will have BAY 94-9343 as an infusion for about 1 hour.
  • Treatment will be monitored with frequent blood tests, heart and lung function tests, and imaging studies. Treatment will continue as long as the tumor does not start growing and no severe side effects develop.

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Study of ABT-700 in Subjects With Advanced Solid Tumors

Purpose: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Approximately 51 to 75 subjects will be enrolled.

Arms
  • Cohort A: Experimental
    • ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700.
    • Intervention: Drug: ABT-700
  • Cohort B: Experimental
    • ABT-700 plus erlotinib 150 mg qd (21-day cycle).
    • Intervention: Drug: ABT-700 plus erlotinib
  • Cohort C: Experimental
    • ABT-700 plus oxaliplatin and capecitabine. ABT-700 IV (Day 1) Oxaliplatin: 130 mg/m2 IV (Day 1) Capecitabine: 1000 mg/m2 Oral (twice daily Days 1 – 14).
    • Intervention: Drug: ABT-700 plus Oxaliplatin and Capecitabine

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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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