Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With...
RET-altered Non Small Cell Lung CancerMedullary Thyroid Cancer46 moreThis is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.
Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy...
Parathyroid DiseasesParathyroid Dysfunction10 moreThe goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
Molecular Analysis and Treatment Options of Thymic Malignancies
Thymic Epithelial TumorThymic Carcinoma1 moreThymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies. In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.
Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced...
Ovarian NeoplasmsFallopian Tube Neoplasms17 moreIt has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.
Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell...
Non-Small Cell Lung CancerSmall Cell Lung Cancer3 moreBackground: - Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it. Objective: - To collect tissue samples for use in the study of lung cancers. Eligibility: - Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors. Design: Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks. Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy. Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body. After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.
French National Observatory of Patients With Thymic Epithelial Tumor
Thymic Epithelial TumorRYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy...
ThymomaAdvanced Thymic Epithelial TumorThe purpose of this study is to evaluate the safety, tolerability and effectiveness of selinexor in patients with advanced thymic epithelial tumor progressing after primary chemotherapy. This is a multicenter, open label phase II trial that uses a Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with at least one platinum containing chemotherapy regimen. This study is comprised of 2 similar phase II trials, one running in US (25 patients) and one running in EU (25 patients): There are two study arms: Arm A: Thymoma Stage 1: 15 patients Stage 2: 10 patients Arm B: Thymic carcinoma Stage 1: 15 patients Stage 2: 10 patients
A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
Prostatic DiseasesGenital Neoplasms9 moreThe purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure. Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials. This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer. The study has three phases: Screening, Treatment and Follow-up Screening: Eligibility will be verified Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery Follow up: Subjects will be followed every 6 months for up to 5 years. In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.
Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)...
Hepatocellular Carcinoma Non-resectableHepatocellular Carcinoma Recurrent13 moreThe primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
NHS-IL12 for Solid Tumors
Epithelial NeoplasmsMalignant3 moreBackground: - The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment. Objectives: - To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments. Eligibility: - Individuals at least 18 years of age with solid tumors that have not responded to standard treatments. Design: Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests. Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.