Purpose: BAY94-9343 is an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin on tumor cells. This study will attempt to answer the following questions:
– What are the side effects of BAY94-9343 when given at different dose levels and schedules?
– What dose level and schedule of BAY94-9343 should be tested in future clinical research studies?
– How much BAY94-9343 is in the blood at specific times after administration?
– Does the treatment with BAY94-9343 show any effect on the tumor growth?
– Are there specific biomarkers that might be able to explain why some patients respond to treatment and others do not?
Mesothelioma
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Purpose: The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
Proton Beam Radiation Therapy in Treating Patients With Recurrent Thoracic Cancer Who Have Received Prior Radiation Therapy
Purpose
This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.
Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin
Purpose:
This is a prospective, open-label, mono-centric, phase I-Ib trial of Tivantinib in combination with Pemetrexed and Carboplatin as first-line therapy in patients with advanced or metastatic cancer suitable for a Carboplatin and Pemetrexed regimen as part of their specific therapy.
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
Purpose:
This trial is to determine the safest dose of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alfa (IFN), and rintatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.
The first phase of this study will determine the safest dose of IFN that can be given in combination with celecoxib and rintatolimod along with a DC vaccine. The doses of celecoxib (400 mg) and rintatolimod (200 mg) will be consistent while the dose of IFN will be increased (5, 10, or 20 MU/m2) as participants are enrolled to the trial. The high dose of IFN in combination with celecoxib and rintatolimod will be used for the next phase of the clinical trial. After surgery, participants will receive 2 cycles of the investigational treatment.
The second phase of this study will test if the investigational treatment has any effects on peritoneal surface malignancies. The doses of the combination determined in the first phase will be used in this phase of the clinical trial. After surgery, participants will receive 2 cycles of the investigational treatment, followed by standard chemotherapy as determined by their oncologist, and then 2 more cycles of the investigational treatment.
Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Purpose: This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients with thoracic cancer receiving radiation therapy to the thorax with or without chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently shown to be helpful for mouth pain in patients receiving radiation therapy. Part of doxepin hydrochloride’s drug action takes place at the surface of the esophagus, which may be helpful in reducing the pain caused by radiation therapy.
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
Purpose: This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor’s blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Purpose: Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.
This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, and D) Mesothelioma. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.
Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study
Purpose: The objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. Feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. The study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach (stage IIIb-IV).
ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
Purpose: The purpose of this study is to determine whether trabectedin is effective in the treatment of malignant pleural mesothelioma (MPM).
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