Purpose: The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) – engineered to express the WT1 protein – in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.
Mesothelioma
Effect of Fas Ligand Polymorphism on Patients With Platinum/Gemcitabine-Treated Malignant Pleural Mesothelioma
Purpose:
To Study the Effect of Polymorphism in Fas Ligand Gene Promoter Region (rs 763110) on Gemcitabine/Platinum regimens used in treatment of malignant pleural mesothelioma (MPM)
Peritoneal Surface Malignancies – Characterization, Models and Treatment Strategies (PSM)
Purpose: The aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).
Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors
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?
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.
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