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Biomarkers in Immunotherapy of Melanoma
Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the...
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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
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Biomarkers of Resiliency in Childhood Cancer Surgery
This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are: 1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery? 2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery? Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will...
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BioMEL- Diagnostic and Prognostic Factors in Melanoma.
The investigators' hypothesis is that cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi all differ in not only clinical characteristics but also molecular and genotypic characteristics. Patients with suspected primary cutaneous melanoma or a differential diagnosis, or secondary melanoma can be asked to participate in the first part of the project and patients with suspected or confirmed secondary (spread) melanoma can be included in the second part of the study. Participants included in the study answer a validated questionnaire regarding epidemiological and phenotypic factors to map medical history, prior UV exposure, family history of melanoma and/or other...
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Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma
Cutaneous melanoma is a bad prognosis skin cancer, which can be treated with immune checkpoint inhibitors (ICI), such as anti-PD-1 (nivolumab, nivo) and anti-CTLA-4 (ipilimumab, ipi). However, about 50% of patients do not respond or relapse within 3 years post therapy induction, and immune-related adverse events (irAEs), such as colitis, are triggered and can be treated with TNF inhibitor (TNFi; ie, infliximab, inflix). The pharmacodynamic impact of TNFi on the immune and clinical responses remain to be clarified. The investigators previously demonstrated that TNFi enhance the efficacy of ICI in mouse melanoma models. Based on preclinical findings, the investigators implemented...
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Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients
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Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients
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Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.
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Bortezomib and Temozolomide in Recurrent Grade-4 Glioma Unmethylated MGMT Promoter (BORTEM-17)
This phase IB/II trial is designed to investigate the safety and survival benefits for patients with recurrent grade-4 with unmethylated MGMT promoter treated with Bortezomib and Temozolomide in a specific schedule.
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BostonGene and Exigent Genomic INsight Study
The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings.
