Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Multiple Cancer Types
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.
Lung, Miscellaneous, Small Cell
Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
This screening study is intended for men and women at least 18 years of age who have advanced solid or hematologic malignancy. The study will assess a subject's human leukocyte antigen (HLA) subtype and tumor antigen expression profile. Based on the results, it will be determined if a subject is eligible to be considered for Adaptimmune sponsored clinical trials testing the safety and efficacy of genetically changed T cells targeting specific tumor antigens. No treatment intervention will occur as part of this screening study. Upon enrollment, subjects will be required to provide a blood sample for HLA subtype analysis. If the results of the analysis match the HLA-A subtypes noted in the inclusion criteria and do not express the HLA subtypes that are exclusionary for the available interventional clinical trial(s), then the subject will be required to provide either an archival tumor specimen or fresh tumor tissue biopsy. The tumor specimen will be screened at a central laboratory for the expression (protein or gene) of multiple antigens which may include, but are not limited to NY-ESO-1 and / or LAGE-1a and MAGE A10. Based upon the results of these diagnostic analyses, if eligible, subjects will be referred to an appropriate available interventional clinical trial(s) at the discretion of the Investigator. Following screening, tumor samples will be retained by Adaptimmune for the purpose of developing and validating in vitro diagnostic (IVD) assay(s) for antigen expression profiling which is required for regulatory approval of a new therapeutic product indication.
The purpose of the Connect® MDS / AML Disease Registry is to provide unique insights into treatment regimens and sequencing of these regimens as they relate to clinical outcomes of patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate molecular and cellular markers that may provide further prognostic classification and / or might be predictive of therapy outcomes.
Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Objectives: To learn more about what makes stem cell transplants and cellular therapies work well such as: - Determine how well recipients recover from their transplants or cellular therapy; - Determine how recovery after a transplant or cellular therapy can be improved; - Determine how access to transplant or cellular therapy for different groups of patients can be improved; - Determine how well donors recover from the collection procedures.
Multiple Cancer Types
The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.
18F-FSPG PET / CT in Imaging Patients with Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
This phase II trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) / computed tomography (CT) to the standard of care fludeoxyglucose F-18 (18F-FDG) PET / CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET / CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET / CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET / CT using a radioactive glucose (sugar), such as 18F-FDG.
Cognitive Assessment and MRI Program in Identifying Cognitive Effects of Androgen Receptor Directed Therapies in Patients with Advanced Prostate Cancer
This clinical trial studies how well cognitive assessment and magnetic resonance imaging (MRI) program work in identifying cognitive effects of androgen receptor directed therapies such as abiraterone acetate and enzalutamide in patients with prostate cancer that has spread from where it started to other places in the body. Cognitive assessment and MRI program may help to assess the cognitive function of patients during treatment and identify genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.
Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents with Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission
Multiple Cancer Types
This randomized clinical trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with newly diagnosed acute lymphoblastic leukemia that shows a decrease in or disappearance of signs and symptoms. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
Pediatric Leukemia, Pediatrics
Multiple Cancer Types
This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn’t get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can’t pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.
Gabapentin Compared to Usual Care in Preventing Mucositis in Participants with Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
This randomized phase III trial studies how well gabapentin and usual care work compared to usual care alone in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) radiation-induced mucositis in patients with head and neck cancer.