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Clinical Trial

S1400, "Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study” (CTRC #14-0036)

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Clinical Trial

Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias

This study evaluates the use of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed/refractory solid tumors or leukemia. The medications cyclophosphamide and etoposide are standard drugs often used together for the treatment of cancer in children with solid tumors or leukemia. Carfilzomib is FDA (Food and Drug Administration) approved in the United States for adults with multiple myeloma (a type of cancer). However, this drug is not approved for the disease being treated in this study. Since carfilzomib has not yet been used in this setting to treat this condition, the investigators must first find the best dose to give. The investigators are looking for the highest dose of carfilzomib that can be given safely. Therefore, not all children taking part in this study will receive the same dose of the study drug in the first part of the trial.

Clinical Trial

THE TEXAS HEPATOCELLULAR CARCINOMA CONSORTIUM (THCCC); RISK STRATIFICATION FOR AND EARLY DETECTION OF LIVER CANCER (U01)

TLI and UTHSCSA will be participating in projects 2 and 4 ,To examine cirrhotic patients and their risk factors for developing liver cancer . Researchers hope to improve ability to prevent liver cancer , and to better identify patients at higher risk for developing liver cancer at an early stage. C. Early detection of HCC in patients with cirrhosis remains suboptimal. The efficacy of HCC surveillance for the early detection of HCC is a subject of intense debate due to the lack of sensitive and specific biomarkers that are well validated in prospective studies. Further, implementation of surveillance in practice is very low. The MIRA aims to develop novel, urgently needed, and highly effective surveillance biomarkers of patients with cirrhosis, and improve the utilization of currently available surveillance strategies. Project 2: Metabolic Syndrome and Risk Prediction of Hepatocellular Carcinoma (PI: H El-Serag). This project will develop risk stratification algorithms based on demographic, clinical, molecular and epidemiological risk profiles to identify cirrhotic patients who might benefit from chemoprevention or intensive surveillance. Our proposed multicenter prospective cohort study of >4000 patients with cirrhosis and up to 4 year follow up (a conservative estimate of 300 new HCC cases) will be the largest cohort study of cirrhotic patients assembled in Texas (and U.S). We will evaluate phenotypic (including molecular endophenotypes) and genotypic aspects of MetS as well as established risk factors.Project 4: Novel Biomarkers for Hepatocellular Carcinoma (PI: L Beretta). This project will identify and validate novel biomarkers for risk stratification and early HCC detection. Although several biomarkers have supporting pre-clinical (phase 1) and case-control (phase 2) data, few have been evaluated in retrospective cohort (phase 3) or prospective cohort (phase 4) studies. The prospective Texas multicenter cohort study of cirrhosis patients (i.e. Phase 3) in which 300 HCC cases will be compared to 600 controls nested in this cohort. We will validate several promising existing markers as well as aim to discover novel biomarkers for HCC detection.

Clinical Trial

DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

A clinical trial screening tool protocol has been developed to facilitate the formulation of research questions; particularly those evaluating factors related to populations that are underrepresented in clinical trials, and address cancer care disparities. This protocol is designed to allow the collection, storage and abstraction of clinical and demographic data obtained during the screening process, using the Oncology Patient Enrollment Network (OPEN), the same informatics system used by investigators participating in NCI-sponsored trials. The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP)5, has been streamlined and integrated into the sites workflow by using OPEN.

Clinical Trial

ALTE1621, Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

This 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.

Clinical Trial

A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)

The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent or in combination with PDR001, administered intravenously (i.v.) in adult patients with advanced solid tumors. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. Once MTD/ RP2D is declared, glioblastoma patients will be enrolled in the phase II part to further assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001.

Clinical Trial

A Pilot Study to Evaluate the Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal cancer (CRC) Patients with Curative Resections.

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Clinical Trial

Alliance A011401 Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.