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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer...
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Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.
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Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome. Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.
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Characterization of the Melanoma-Specific Immune Response
The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.
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Characterizing Sleep Among Long-term Survivors of Childhood Cancer
The patients are being asked to take part in this clinical trial because they received cancer treatment as a child at St. Jude. The study comprehensively examines sleep among three distinct diagnostic groups of survivors in the SJLIFE cohort: ALL, CNS tumors, and non-CNS solid tumors. Primary Objective The primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood ALL, CNS tumors, and non- CNS solid tumors. Exploratory Objective The exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in SJLIFE.
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Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery
This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma. The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma. Participants will receive one cycle of retifanlimab plus platinum-etoposide chemotherapy prior to their scheduled surgery.
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Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity. GCC2020 is a prospective open-label phase 1 trial to determine the best safe dose of ibrutinib to use in combination with a previously studied chemo-immunotherapy regimen, comprised of the...
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Chemoradiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail GBM Patients
Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen. In particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS. The...
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Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for...
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Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary
there is a need for improving chemotherapy regimen for metastatic G3 NEC of GEP and Unknown origin and this goal may be achieved through more "personalized" chemotherapy regimen.the hypothesis is that mFOLFIRINOX regimen could be a good candidate for challenging the platinum-etoposide regimen in patients with metastatic G3 NEC of GEP or unknown origin. Furthermore, in order to get insights in the putative predictive biomarkers of efficacy of these two regimens, an effort toward a precise molecular characterization of these tumors is required in order to be able to define which subgroup of G3 NEC needs to be treated by which chemotherapy regimen. The FOLFIRINEC trial is set up in...
