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Neoplasm Metastasis clinical trials

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NCT ID: NCT02082587 Completed - Brain Metastases Clinical Trials

Toronto BNB Pilot Study

Start date: September 2014
Phase: N/A
Study type: Observational

As treatments improve and patients live longer with cancer, even after it has spread to the brain, efforts to improve quality of life are growing. Neurocognitive function (thinking ability and memory) is an area of particular concern for patients with brain metastases (cancer that can spread to the brain). Although there are established tests to measure neurocognitive function, these require a face-to-face assessment and can take a long time to complete. As a result, efforts to use these tests to measure changes in neurocognitive function in patients following treatment for brain metastases have resulted in a large proportion of patients who do not return for follow-up. This has limited the ability to evaluate the impact of current treatments on neurocognitive function. This study aims to evaluate a shorter, telephone-based neurocognitive assessment tool, which would make it easier for patients to complete these tests in follow-up. If this new tool is found to reliably measure neurocognitive function, it could be used for future studies evaluating new interventions that prevent or treat neurocognitive deterioration following treatment of brain metastases. This is the first prospective study to evaluate the feasibility and reliability of a novel telephone-based brief neurocognitive assessment battery (Toronto BNB) compared with the same battery delivered face-to-face in this population. The investigators hypothesize that telephone administration of this brief neurocognitive battery will reliably evaluate neurocognitive function and improve patient ability to complete follow-up assessments.

NCT ID: NCT02080949 Withdrawn - Brain Metastases Clinical Trials

Phase I Dose Escalation in Patients With 1-3 Unresectable Brain Metastases

Start date: January 2011
Phase: Phase 1
Study type: Interventional

Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment is based on whole brain radiation therapy and local treatment of metastases as neurosurgery or radiosurgery. However, many cases can not receive a standard local treatment, and local relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are retrospective studies of increased radiation dose at the site of metastasis with hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no controlled studies regarding the safety of radiation dose in these situations. This study is a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for surgery or RS.

NCT ID: NCT02078700 Completed - Lung Cancer Clinical Trials

Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. Feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. The study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach (stage IIIb-IV).

NCT ID: NCT02071056 Completed - Clinical trials for Leptomeningeal Metastasis

Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)

Start date: May 2014
Phase:
Study type: Observational

The purpose of this study is to learn whether the DNA from cancer tumor cells can be found in the cerebral spinal fluid (CSF) that bathes the brain and spinal cord of patients before malignant the cancer cells themselves are able to be found in the CSF. The researchers doing this study hope this information can be used to develop a way to diagnose LM earlier .

NCT ID: NCT02065466 Withdrawn - Metastatic Melanoma Clinical Trials

Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

1.1. Primary Objectives 1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma. - To define the MTD of the combination (Phase I component). - To determine progression free survival (Phase II component). 1.2. Secondary Objectives 1. To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases. 2. To define the toxicity of the regimen. 3. To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases. 4. To use the data generated to plan definitive controlled clinical trials of the combination. 5. To determine the overall response rate (Phase II component).

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: NCT02061085 Completed - Breast Neoplasm Clinical Trials

Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

MERIBEL
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma previously exposed to taxanes for early stage. The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.

NCT ID: NCT02058953 Completed - Melanoma Clinical Trials

CNS and Extracranial Tumor Tissues, CSF, and Blood From Patients With Melanoma Brain Metastases

13-052
Start date: August 12, 2014
Phase:
Study type: Observational

The purpose of this study is to collect and bank samples of blood and tissues (such as brain tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples. The investigator hopes that by studying the biomarkers, he can develop tests in the future that can detect central nervous system (CNS) metastasis in blood samples before they show up on x-ray and develop medicines that can specifically target CNS metastasis.

NCT ID: NCT02053324 Terminated - Liver Metastases Clinical Trials

AvidinOX + [177Lu]DOTA-biotin (or 177Lu-ST2210) Complex in Patients With Liver Metastases From Colorectal Cancer

Start date: November 11, 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess a new treatment for patients with liver tumor metastases from colorectal cancer. The treatment has never been used in humans before. The treatment foresees the use of two compounds: AvdinOX and [177Lu]DOTA-biotin. AvidinOX is a new compound, essentially a natural protein obtained from hen eggs, while [177Lu]DOTA-biotin is a new chemical compound resulting from the combination of the DOTA-biotin (also deriving from a natural vitamin which is biotin) with the 177Lutetium, an atom which emits radiation. AvidinOX will be injected directly into the metastases in the liver and [177Lu]DOTA-biotin will be injected into the arm vein. One specific property of AvidinOX is that it chemically links to the tumor tissues when it is injected while maintaining the capacity to take up [177Lu]DOTA-biotin. Once locally bound in tumor tissue, AvidinOX becomes an "artificial receptor" for intravenously injected [177Lu]DOTA-biotin, which allows an internal radiation therapy of the tumor tissue. The treatment of liver metastases with local injection of AvidinOX and the following intra-venous injection of [177Lu]DOTA-biotin could be simpler and more tolerable than the current available treatments.

NCT ID: NCT02051218 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

Start date: July 16, 2014
Phase: Phase 3
Study type: Interventional

The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained if administered only every 12 weeks as compared to every 4 weeks.