Clinical Trials

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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, Terminated
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Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome

Rationale: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with pemetrexed disodium may kill more cancer cells.

Purpose: This phase I/II trial is studying the side effects and best dose of gemcitabine hydrochloride when given together with pemetrexed disodium and to see how well they work in treating patients with advanced mycosis fungoides or Sézary syndrome.

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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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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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Categories:
Clinical Trials, Closed, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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Cryotherapy in Treating Patients With Lung Cancer

Purpose:
This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.

Arm: Treatment (cryoablation): Experimental. Patients undergo CT-guided CA.
Interventions:

  • Procedure: cryotherapy
  • Procedure: quality-of-life assessment

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