Mesothelioma

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Clinical Trials, Closed, Mesothelioma, Mesothelioma of the Tunica Vaginalis, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
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Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment

Purpose: Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless of the therapeutic approach.

The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12 months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no dose-limiting toxicities observed.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum

Purpose: Increasing evidence indicates that activation of stem cell gene expression is a common mechanism by which environmental carcinogens mediate initiation and progression of thoracic malignancies. Similar mechanisms appear to contribute to extra-thoracic malignancies that metastasize to the chest. Utilization of pharmacologic agents, which target gene regulatory networks mediating stemness may be novel strategies for treatment of these neoplasms. Recent studies performed in the Thoracic Oncology Laboratory, SB/NCI, demonstrate that under exposure conditions potentially achievable in clinical settings, mithramycin diminishes stem cell gene expression and markedly inhibits growth of lung and esophageal cancer and MPM cells in vitro and in vivo. These finding add to other recent preclinical studies demonstrating impressive anti-tumor activity of mithramycin in epithelial malignancies and sarcomas that frequently metastasize to the thorax.

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Clinical Trials, Mesothelioma, Peritoneal Mesothelioma, Recruiting, Status
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Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed

Purpose: The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.

Registry
Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy

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Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
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A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies

Purpose: The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, docetaxel, or pemetrexed.

Experimental; Arm A: HGS1036 + Paclitaxel + Carboplatin
Drug: HGS1036 + Paclitaxel + Carboplatin
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg∙min/mL, IV every 3 weeks on Day 1 of each 21-day cycle.
Experimental; Arm B:
HGS1036 + Cisplatin + Etoposide
Drug: HGS1036 + Cisplatin + Etoposide
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle.
Experimental; Arm C:
HGS1036 + Docetaxel
Drug: HGS1036 + Docetaxel
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle.
Experimental; Arm D:
HGS1036 + Pemetrexed
Drug: HGS1036 + Pemetrexed
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and pemetrexed 500 mg/m2, IV on Day 1 of each 21-day cycle.

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Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
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PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

Purpose: The PIT (Prophylactic Irradiation of Tracts) trial will determine whether or not PIT radiotherapy is effective in preventing or delaying the onset of chest nodules in patients with Mesothelioma.

Arm: Experimental: PIT Arm
Radiation: Prophylactic Irradiation of Tracts (PIT)
21 Gy in 3 fractions
Other Name: Radiation
Arm: No Intervention: No PIT Arm

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Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Status
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Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma

Purpose: The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.

Arms: Experimental: Treatment (enzyme inhibitor therapy)
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride

  • Given PO
  • Other Names:
    • CP-358,774
    • erlotinib
    • OSI-774
Other: laboratory biomarker analysis

  • Correlative studies

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Categories:
Clinical Trials, Closed, Mesothelioma, Status
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Do Your Genes Put You at a Higher Risk of Developing Mesothelioma

Purpose: The purpose of this research study is to investigate the possibility that a person’s genes put a person at a higher risk of developing mesothelioma. The investigators will examine genes from DNA (genetic material) isolated from blood. This study will also examine the impact of environmental and work exposures and family history of common cancers on the development of mesothelioma. The genetic markers in this study will basically identify how a person’s body processes frequently encountered environmental pollutants and will not tell about chromosomes, specific diseases, or other potential health problems.

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Categories:
Clinical Trials, Closed, Lung Cancer, Mesothelioma, Pleural Mesothelioma, Status
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Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)

Purpose: Malignant pleural mesothelioma (MPM) is a rapidly lethal cancer arising from the parietal pleural mesothelium, and is associated with exposure to asbestos.

Once a rare disease, it is increasing in incidence in the UK and is presently more common than cervical cancer. MPM is characterized by local invasion of adjacent structures including the chest wall, mediastinum, diaphragm and pericardium resulting in progressive shortness of breath.

Median survival with best supportive care alone is approximately 6-9 months and most cases of mesothelioma present in the advanced setting. Therefore this trial will be looking at whether a new drug, Ganetespib has any improvement on survival for these types of patients.

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Clinical Trials, Closed, Mesothelioma, Status
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Treating Cancer With Anti-mesothelin Modified Lymphocytes

Background:
A possible new procedure for treating people with advanced cancer uses blood cells known as peripheral blood cells. Once these cells are modified and grown in a laboratory, they can be used to target and destroy cancer cells. Some cells can be modified to target a protein called mesothelin that is found on some types of cancer cells. By blocking mesothelin, it is expected that these cells will help shrink existing tumors. However, it is possible that the cells will not have this effect. Researchers want to try this therapy on people who have advanced cancer that has not responded to standard treatments.
Objectives:
To test the safety and effectiveness of anti-mesothelin modified cells for advanced cancer.
Eligibility:
Individuals at least 18 years of age with advanced cancer that involves mesothelin and has not responded to standard treatments.
Design:
  • Participants will be screened with a physical exam and medical history. They will also have imaging studies before starting treatment. Blood and urine samples will be collected.
  • Participants will have leukapheresis to collect peripheral blood cells. These cells will be modified for the treatment.
  • Participants will have chemotherapy to prepare the immune system to receive the modified cells. The chemotherapy will take place for 1 week before the cell infusion.
  • Participants will receive their modified cells as an infusion. They will also receive interleukin-2 to help boost their immune system response. The interleukin-2 will be given every 8 hours for up to 15 doses.
  • Participants will recover from the infusion treatment in the hospital for at least 2 weeks.
  • The results of the treatment will be monitored with frequent follow-up blood tests and imaging studies.

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Categories:
Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
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A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)

Purpose: This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy.

We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person’s immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.

Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone.

Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.

Arms: Experimental: TroVax®
In this single-arm study, all participants will receive 9 injections of the TroVax® vaccine, plus standard cisplatin and pemetrexed chemotherapy.
Interventions
Biological: TroVax®: Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.
Drug: Pemetrexed
500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.
Drug: Cisplatin
75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13
Dietary Supplement: Vitamin B12
1000μg intramuscular, Day 2 of weeks 3 and 12
Dietary Supplement: Folic Acid
400μg oral daily from Day 2 of week 3 to Day 2 of week 16
Drug: Dexamethasone
4mg BD, Days 2-6 of weeks 4, 7, 10, 13

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