Clinical Trials: 'Closed' Category

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Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

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 to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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.

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma

Purpose: To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

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.

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (ABOCA1)

Purpose: This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

Tomotherapy Treatment for Mesothelioma

Purpose: mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to the disease. While a very small number of patients qualify for aggressive treatment with surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of patients have incurable disease. The treatment options currently available, including chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and improving life expectancy. This trial explores the use of new radiation technology (tomotherapy), to treat mesothelioma more aggressively than has been possible before. Tomotherapy’s ability to treat unusual shaped tumours, particularly when they are wrapped around sensitive normal tissues (the lung), enable higher doses of radiation to be used and this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the breathing, symptoms, and quality of life of the patients before and after treatment

Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma

Purpose
Determine the highest tolerable dose of drug combination (cisplatin, pemetrexed [Alimta®], and imatinib mesylate [Gleevec®]) that can be given to patients with unresectable or metastatic malignant mesothelioma.

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

Purpose: This is a Phase 2, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 180 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, and a 90-day follow-up period.

Arms and Assigned Interventions:

Experimental: Tremelimumab
Drug: Tremelimumab
Tremelimumab is to be administered as an IV solution, followed by observation.
placebo Comparator: placebo
Drug: placebo
placebo is to be administered as an IV solution, followed by observation.

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.

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

Purpose: The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

Arms

Experimental: infusion of zoledronic acid
Zoledronic acid will be administered on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Drug: Zometa (zoledronic acid): Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Background:
IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.
Objectives:
To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
Eligibility:
Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
Design:
  • * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies.
  • * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed.
  • * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.

Last update: January 19, 2018. 04:57:31 pm.