Clinical Trials

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma

Rational: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

Purpose: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.

Experimental Arm: single arm with Tremelimumab
Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
Assigned Intervention:

  • Drug: Tremelimumab
    Tremelimumab is administered as endovenous infusion
  • Other Name: CP-675,206

Read More »

Date:
Categories:
Clinical Trials, Mesothelioma, Status
Tags:
Comments:
0

A Study of LY3023414 in Participants With Advanced Cancer

Purpose: The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer, including but not limited to lymphoma, breast cancer, and mesothelioma. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have.

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast cancer and mesothelioma.

Experimental Arm: Part A: LY3023414 Once Daily
LY3023414 administered orally once daily (QD) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation.
Assigned Interventions:

  • Drug: LY3023414
    Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
Experimental Arm: Part A2: LY3023414 Twice Daily
LY3023414 administered orally twice daily (BID) at escalating doses for two 21 day cycles to participants with advanced/metastatic cancer (including lymphoma); participants receiving benefit may continue until disease progression or discontinuation.
Assigned Interventions:

  • Drug: LY3023414
    Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
Experimental Arm: Part B1 : LY3023414 + Midazolam
LY3023414 administered orally QD or BID for two 21 day cycles to participants with advanced/metastatic cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 0.2 mg midazolam administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
Assigned Interventions:

  • Drug: LY3023414
    Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
  • Drug: Midazolam
    0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
Experimental Arm: Part B2: LY3023414 + Letrozole
LY3023414 administered orally QD or BID for two 21 day cycles to participants with advanced/metastatic breast cancer; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A. 25 mg Letrozole administered orally QD.
Assigned Interventions:

  • Drug: LY3023414
    Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.
  • Drug: Letrozole
    25 mg administered orally QD.
Experimental Arm: Part B3: LY3023414
LY3023414 administered orally QD or BID for two 21 day cycles to participants with malignant mesothelioma; participants receiving benefit may continue until disease progression or discontinuation. Dose based on Part A.
  • Assigned Interventions: Drug: LY3023414
    Administered orally QD or BID for a 21 day Cycle. Dose of 20 to 600 mg, as determined in Part A.

Read More »

Date:
Categories:
Clinical Trials, Mesothelioma, Pleural Mesothelioma, Recruiting, Status
Tags:
Comments:
0

Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication for Malignant Pleural Mesothelioma

Purpose: The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication in a phase I and IIa study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model.

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Mesothelioma of the Tunica Vaginalis, Peritoneal Mesothelioma, Pleural Mesothelioma, Status
Tags:
Comments:
0

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.

Read More »

Date:
Categories:
Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
Tags:
Comments:
0

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.

Read More »

Date:
Categories:
Clinical Trials, Mesothelioma, Peritoneal Mesothelioma, Recruiting, Status
Tags:
Comments:
0

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Lung Cancer, Mesothelioma, Status
Tags:
Comments:
0

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.

Read More »

Date:
Categories:
Clinical Trials, Mesothelioma, Pleural Mesothelioma, Status, Terminated
Tags:
Comments:
0

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Peritoneal Mesothelioma, Status
Tags:
Comments:
0

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

Read More »

Date:
Categories:
Clinical Trials, Closed, Mesothelioma, Status
Tags:
Comments:
0

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.

Read More »