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Metastatic Cancer clinical trials

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NCT ID: NCT02141152 Completed - Metastatic Cancer Clinical Trials

Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model

NEXT-1
Start date: February 2015
Phase: N/A
Study type: Observational

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important. To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.

NCT ID: NCT02062359 Completed - Metastatic Cancer Clinical Trials

T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Melanoma

Start date: February 2014
Phase: Phase 2
Study type: Interventional

Background: The NCI Surgery Branch has developed an experimental therapy for treating patients with melanoma that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying them, and then giving the cells back to the patient. In a previous study, the NCI Surgery Branch used the anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor-fighting cells (anti-ESO-1 cells). About half of the patients who received this treatment experienced shrinking of their tumors. In this study, we are using a slightly different method of producing the anti-ESO-1 cells selected for a specific cell type, which we hope, will be better in making the tumors shrink. Objectives: The purpose of this study is to see if these tumor fighting cells (genetically modified cells) that express the receptor for the ESO-1 molecule on their surface can cause melanoma tumors to shrink and to see if this treatment is safe. Eligibility: -Adults 18 and older with cancer that has the ESO-1 molecule on tumor surfaces Design: - Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti ESO-1 cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-ESO 1 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.

NCT ID: NCT02050256 Withdrawn - Clinical trials for Chronic Obstructive Pulmonary Disease

Improving End-of-life Care by Continuing Medical Education and Electronic Decision Making Support for General Practitioners

Start date: February 2014
Phase: N/A
Study type: Interventional

Background: Optimizing the basic palliative care has been shown beneficial to patients in end-of-life care, the general practitioner (GP) having a pivotal role in the health care system, providing comprehensive and continued medical care. The aim of the study is to investigate the effect of a complex intervention in general practice on GPs' awareness of and confidence in providing end-of-life care. Method: A follow-up study among 404 general practices in Central Denmark Region. The participating general practices will get the opportunity to receive education in palliative care and access to an electronic support, which provides advice on palliative care and an overview of the palliative population in each medical practice. The education and the support will focus on patients suffering from either metastatic cancer or chronic obstructive pulmonary disease (GOLD stage 4). The end-of-life care delivered by the GPs to their deceased patients will be analysed, based on questionnaires to GPs and register data related to the deceased patients before and after the intervention, . Primary outcomes: Place of death of deceased patients, time spent at home, and number of hospital admissions in the last three months of the patients' lives. Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be assessed in questionnaires.

NCT ID: NCT02049593 Completed - Metastatic Cancer Clinical Trials

PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Start date: June 12, 2014
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and the best dose of poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor BMN-673 when given together with temozolomide or irinotecan hydrochloride in treating patients with locally advanced or metastatic solid tumors. PARP inhibitor BMN-673 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may help temozolomide and irinotecan hydrochloride work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving PARP inhibitor BMN-673 with temozolomide or irinotecan hydrochloride may be an effective treatment for patients with advanced solid tumors.

NCT ID: NCT02034981 Completed - Solid Tumors Clinical Trials

Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1

AcSé
Start date: August 2013
Phase: Phase 2
Study type: Interventional

This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification). For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.

NCT ID: NCT02000739 Withdrawn - Metastatic Cancer Clinical Trials

Genetically-informed Therapies for Patients With Metastatic Cancer

GENIUS
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Genetic mutations associated with cancer are being discovered and new treatments are being created to treat people whose cancer tumors have certain genetic mutations. Genetic sequencing of a tumor can be done, and in this study that information is sent to a company called "N-of-One." They will match each patient's tumor's genetic profile to targeted therapies. The targeted therapies may be use of FDA-approved drugs, off-label use of FDA-approved drugs, or use of experimental drugs in clinical research studies open at various locations in the region. The purpose of the study is to compare the length of time it takes for a tumor to grow in people who receive the standard treatment for metastatic cancer to the length of time it takes for a tumor to grow in people who receive a drug specifically targeted for their cancer's genetic mutation. Investigators will do a kind of genetic testing called "DNA sequencing". Everyone who takes part in this trial will have genetic testing done on their cancer tumor tissue here at Dartmouth. The results of the DNA sequencing will be sent to N-of-One as noted above. The treatment participants get will depend on the results of the DNA sequencing and the availability of targeted therapies that match the genetic profile of the tumor identified by the DNA sequencing. If there is no genetic mutation that can be identified with current DNA sequencing, participants will receive the standard treatment for metastatic cancer. If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant. Because there are many drugs that may be used in this study, the investigator cannot advise in advance whether or not the drug a participant might receive has been approved by the U.S. Food and Drug Administration (FDA).

NCT ID: NCT01991938 Terminated - Lymphoma Clinical Trials

Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples.

NCT ID: NCT01991015 Completed - Metastatic Cancer Clinical Trials

Goals of Care Discussions for Hospitalized Patients With Advanced Cancer

Start date: November 2013
Phase: N/A
Study type: Observational

The goal of this study is to better understand gender differences in end-of-life communication between physicians and patients with advanced cancer in the hospital.

NCT ID: NCT01957735 Completed - Cancer Clinical Trials

BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.

NCT ID: NCT01929941 Terminated - Breast Cancer Clinical Trials

An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1 and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of patients with solid tumors. Each patient group will participate in a phase of the study which is divided into two parts. The patient groups will be enrolled in a sequential manner starting with Patient Group 1. Patient Group 1 Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986 as monotherapy. Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial pharmacologic effect. These doses will be used in Part 2 of the study. Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and preliminary clinical activity of INCB047986 using the doses identified in Part 1. Group 2 Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or urothelial cancer. Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second line), triple-negative breast cancer (second line) or urothelial cancer (second line). Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers, and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients enrolled in this phase will be limited to those with advanced or metastatic pancreatic cancer.