Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This is an open-label, dose-escalation / dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and / or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML / MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.

This trial studies how well tumor-treating fields therapy works in preventing brain tumors in patients with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and / or reverse tumor growth by disrupting the way cancer cells grow.

Background: -Patients who are being evaluated and / or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: - To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. - To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and / or treated for cancer at the NIH Clinical Center and adult patients from participating sites. Design: - This is a multicenter tissue procurement protocol with NCI as the coordinating center. - For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. - For pediatric patients: tumor biopsy / resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. - Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents / guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. - This study has three separate consent forms: one for adult patients at the NIH Clinical Center to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Center only), can opt to donate samples to create preclinical models to study tumor biology and genetics, and to develop new therapies for cancer. - Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.