50 studies found
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Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

PRIMARY OBJECTIVES: I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known. II. Compare the sensitivity of digital droplet...

Fluid Biopsy for the Diagnosis of Lung Cancer

PRIMARY OBJECTIVE: I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma. SECONDARY OBJECTIVES: I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer. II. To determine the relative contribution of cell based high definition circulating tumor...

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer...

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a...

Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients

PRIMARY OBJECTIVES: I. To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability. II. To test the hypothesis that changes in the...

Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases

PRIMARY OBJECTIVES: I. To optimize and technically validate specially-tailored acquisition and reconstruction (STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK) parameter maps. SECONDARY OBJECTIVES: I. To develop a robust clinical implementation of STAR DCE-MRI. II. To clinically evaluate STAR DCE-MRI in patients with brain tumors. OUTLINE:...

Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

BACKGROUND Recent investigations have shown that mutations in epigenetic regulators are common, both in the apparently normal hematopoiesis of the elderly and in patients (pts) with myeloid cancers. It was long anticipated that DNA methylation was a permanent silencing mark, but with the discovery of the ten eleven translocation (TET)...

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R)...

Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

PRIMARY OBJECTIVES: I. To evaluate a novel clinical assay (Myeloid Derived Suppressor Cells [MDSC] Clinical Assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant renal cell carcinoma in patients. II. Determine mean MDSC level, intra-subject variability, and...

Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

PRIMARY OBJECTIVES: I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting. II. Optimize data analysis methods and software usage to create a metabolic profile for...

MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer

PRIMARY OBJECTIVES: I. To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant bladder cancer in patients. II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3 groups...

Norris ORIEN Total Cancer Care

PRIMARY OBJECTIVES: I. To establish a longitudinal study of clinical and related data from patients with or at risk for cancer. II. To establish a large biospecimen repository that is linked to clinical and related data. III. To follow patients through their lifetime though passive or active follow-up. IV. To...

AFPᶜ³³²T in Advanced HCC

This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The...

Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers

PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory agents, cellular therapies, stem cell transplantation) and compare to changes in patients receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification, functional analysis...

Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma

PRIMARY OBJECTIVES: I. To evaluate the maximum tolerated combination and safety profile of multi-fraction radiosurgery with concurrent nivolumab plus or minus ipilimumab for recurrent radiation-relapsed high-grade meningioma. (Phase I) II. To evaluate the objective response rate (ORR) of multi-fraction radiosurgery with concurrent nivolumab plus or minus ipilimumab for recurrent radiation-relapsed...

De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

PRIMARY OBJECTIVES: I. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) II. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority...

Epidemiology of Young Lung Cancer - Survey

This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.

Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. SECONDARY...

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

PRIMARY OBJECTIVES: I. To determine if 3-year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2-positive breast cancer who achieve pathologic complete response (pCR) (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or Food and Drug Administration [FDA] approved...

A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. (Nonclinical safety studies showed no findings...

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

PRIMARY OBJECTIVE: I. To compare the overall survival (OS) in molecularly selected patients with metastatic colorectal cancer (CRC) receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib). SECONDARY OBJECTIVES: I. To compare the progression free survival (PFS) in molecularly selected patients with metastatic CRC receiving panitumumab rechallenge versus standard therapy...

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced MCC or cSCC

Approximately twenty adult patients (≥ 18 years of age), of any sex, ethnicity, and race with histologically confirmed MCC or cSCC with accessible lesions, will be eligible for study enrollment and treatment with IFx-Hu2.0 (i.e. 20 total patients across both indications). These types of non-melanoma cancers are very rare in...

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

PRIMARY OBJECTIVE: I. To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab. SECONDARY OBJECTIVES: I. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. II. To determine overall response rate (ORR), rates of...

Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer

PRIMARY OBJECTIVE: I. To assess the objective response rate, defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy with cabozantinib S-malate (XL184 [cabozantinib]), nivolumab, and ipilimumab (CaboNivoIpi). SECONDARY OBJECTIVES: I. To assess duration...

A Study of miRNA 371 in Patients With Germ Cell Tumors

PRIMARY OBJECTIVE: I. To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy. SECONDARY OBJECTIVES: I. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients...

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