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Melanoma clinical trials

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NCT ID: NCT02068079 Withdrawn - Melanoma Clinical Trials

A Pilot Study of Trientine With Vemurafenib for the Treatment BRAF Mutated Metastatic Melanoma

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of combination therapy with vemurafenib and trientine in patients with BRAF mutated metastatic melanoma. Vemurafenib is a drug that is currently approved by the United States Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the "BRAF" gene. Preclinical data suggests that use of a copper chelator (reducer) is a strategy to block cellular signaling activity which would result in anti-tumor effects (slow tumor growth). Trientine is a copper chelator and is FDA approved for the treatment of Wilson's disease (a disease of copper metabolism) and is generally well tolerated. It works by binding to copper to help remove it from the body. Trientine is not FDA approved for the treatment of melanoma and its use in this study is investigational. "Investigational" means the study drug is still being tested in research studies. All patients will receive vemurafenib at 960mg PO twice daily with continuous dosing in combination with trientine in escalating doses. The dose of trientine will depend on what portion of the study. In order to participate in the study, patients must test positive for the change (mutation) in the BRAF gene.

NCT ID: NCT02065466 Withdrawn - Metastatic Melanoma Clinical Trials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: NCT02061007 Withdrawn - Melanoma Clinical Trials

Biomarker Correlates of Hypoxia in Metastatic Melanoma

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

The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron emission tomography (PET) imaging can be used to help doctors determine how much oxygen a tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in the current study. If the study is successful, then imaging can be used to determine a tumor's oxygen status even in patients who are not getting surgery. Investigators want to find out how much oxygen is in the participants tumor based on how much pimo is present, and correlate this with the results of their MRI and 18F-fluoromisonidazole (FMISO) PET scan. This study is also testing the investigational radioactive substance known as FMISO. FMISO is used during PET scans to help doctors see how much oxygen a tumor is getting. Participants might be asked to participate in an optional PET scan using FMISO.

NCT ID: NCT01933061 Withdrawn - Metastatic Melanoma Clinical Trials

Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma

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

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.

NCT ID: NCT01930968 Withdrawn - Ocular Melanoma Clinical Trials

Definity for Ultrasound of Intraocular Tumors

Start date: February 2022
Phase:
Study type: Observational

The study will test the usefulness of a contrast agent to help image tumors in the eye. In this study, patients with eye melanoma who are going to have their eye removed, will have their eye imaged by ultrasound (sound waves) before and after intravenous injection of microbubbles. The pathology characteristics of the tumor in the removed eye will be compared with the images.

NCT ID: NCT01867619 Withdrawn - Melanoma Clinical Trials

Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The primary objective of the phase II study is to assess the objective (CR+PR) response rate at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the brain. Secondary objectives include the evaluation of objective response in the extracranial metastases, duration of response and overall survival.

NCT ID: NCT01851408 Withdrawn - Melanoma Clinical Trials

Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

Start date: April 2006
Phase: Phase 2
Study type: Interventional

This phase II portion of the trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temsirolimus may kill more tumor cells.

NCT ID: NCT01843738 Withdrawn - Stage IV Melanoma Clinical Trials

Radiation Use During Vemurafenib Treatment

Start date: June 2017
Phase: Phase 1
Study type: Interventional

Patients are being asked to take part because they have melanoma that has spread to other organs in their body (metastatic). As part of this study, patients will receive radiation therapy and an approved drug (Vemurafenib).

NCT ID: NCT01833767 Withdrawn - Metastatic Melanoma Clinical Trials

Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

NCT ID: NCT01826864 Withdrawn - Stage IIC Melanoma Clinical Trials

Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma

Start date: August 5, 2011
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.