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Melanoma clinical trials

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NCT ID: NCT01519323 Recruiting - Malignant Melanoma Clinical Trials

BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

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

This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric patients (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Patients will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01438658 Recruiting - Uveal Melanoma Clinical Trials

Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma

UM
Start date: September 2011
Phase: N/A
Study type: Observational

Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients. Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma. The investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.

NCT ID: NCT01409733 Recruiting - Clinical trials for Stage IV Melanoma Patients With Unresectable Liver Metastases

TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients

Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20 patients, this is a feasibility study. the patients profile is patients with stage IV Melanoma with liver metastases.

NCT ID: NCT01331915 Recruiting - Melanoma Clinical Trials

Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma Patients

THERAVAC
Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease. The primary objective is to analyze the safety of the inreasing doses of vaccine. The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.

NCT ID: NCT01281722 Recruiting - Melanoma; Clinical Trials

Role of SLURP-1 in Melanoma and Melanoma Stem Cells

Start date: January 2011
Phase: N/A
Study type: Observational

Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart. SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor related protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR) and it regulates epidermal homeostasis and T-cell function. The preliminary results of comparing human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected members from the family with MDM revealed that T-cell activation was impaired in PBMCs with the heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed melanoma.) Since there is currently no effective treatment for metastatic melanoma, identifying novel molecular mechanisms may lead to development of new treatments for metastatic melanomas. Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis: 1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic potential. 2.Higher frequencies of cells capable of initiating melanoma xenografts when using IL2Rγ-/- NOD SCID mice. These data confirmed the interaction between T cells and MSCs. In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs. Investigating and verifying the interaction between T-cells from patients with MDM and melanoma cells to confirm the SLURP-1 function of tumorigenesis in xenotransplant mice (IL2Rγ-/- NOD SCID) model. To reveal the role of SLURP-1 silencing in melanoma cell lines by using not only A2058 , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and ABCB5- melanoma cells through the tumorigenesis, apoptosis,angiogenesis, proliferation, melanosphere formation assays. The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.

NCT ID: NCT01272609 Recruiting - Melanoma Clinical Trials

Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel

Start date: January 2011
Phase: Phase 3
Study type: Interventional

Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS. Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.

NCT ID: NCT01217398 Recruiting - Clinical trials for Intraocular Melanoma

Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

Start date: October 2009
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

NCT ID: NCT01205815 Recruiting - Melanoma Clinical Trials

Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment

Start date: June 3, 2010
Phase:
Study type: Observational

The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.

NCT ID: NCT01168050 Recruiting - Stage IV Melanoma Clinical Trials

Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.

NILOMEL
Start date: July 2010
Phase: Phase 2
Study type: Interventional

NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include: - Disease control rate (complete, partial response and stable disease) - Metabolic response - Tolerance NCI CTCAE Version 3.0 - Biomarkers associated to response and disease control.

NCT ID: NCT01092585 Recruiting - Melanoma Clinical Trials

Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH

Start date: February 2010
Phase: Phase 2
Study type: Interventional

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).