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Melanoma clinical trials

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NCT ID: NCT01355120 Completed - Ocular Melanoma Clinical Trials

THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease

DeCOG
Start date: October 2011
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma. The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.

NCT ID: NCT01341158 Completed - Clinical trials for Locoregional Metastases in Malignant Melanoma Stages IIIB/C

NAM-Trial: Multiferon in Malignant Melanoma

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.

NCT ID: NCT01339663 Completed - Stage IV Melanoma Clinical Trials

Vaccine Therapy Following Therapeutic Autologous Lymphocytes and Cyclophosphamide in Treating Patients With Metastatic Melanoma

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of autologous T-antigen-presenting cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from melanoma antigen may help the body build an effective immune response to kill tumor cells and may boost the effect of the CTL. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving T-APC vaccine after CTL and cyclophosphamide may be an effective treatment for melanoma

NCT ID: NCT01338389 Completed - Uveal Melanoma Clinical Trials

Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

Start date: June 25, 2012
Phase: N/A
Study type: Interventional

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present. Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans. The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.

NCT ID: NCT01336270 Completed - Melanoma Clinical Trials

Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients

IMMUMELA
Start date: May 2011
Phase: N/A
Study type: Observational

Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.

NCT ID: NCT01335009 Completed - Metastatic Melanoma Clinical Trials

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

Start date: May 16, 2011
Phase: Phase 2
Study type: Interventional

This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).

NCT ID: NCT01334008 Completed - Clinical trials for Choroidal Melanoma, Diffuse

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Start date: April 2011
Phase: N/A
Study type: Interventional

Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

NCT ID: NCT01328535 Completed - Stage IV Melanoma Clinical Trials

Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Start date: January 2011
Phase: Phase 2
Study type: Interventional

This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells

NCT ID: NCT01323517 Completed - Melanoma Clinical Trials

Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab, to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the immune system (the body's natural defense system that helps fight infections) uses to quiet an immune response. The study drug works by blocking this protein and allowing the immune system to become more active. This study will investigate the effects, of combining ILI (using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study drug, Ipilimumab on advanced Melanoma cancer.

NCT ID: NCT01321437 Completed - Melanoma Clinical Trials

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine the efficacy of Axitinib in treating individuals with Stage III melanoma.