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Melanoma clinical trials

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NCT ID: NCT01970527 Terminated - Recurrent Melanoma Clinical Trials

Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

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

This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.

NCT ID: NCT01950195 Terminated - Clinical trials for Newly Diagnosed Melanoma Metastases in the Brain and Spine

SRS (Stereotactic Radiosurgery) Plus Ipilimumab

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

This research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of care uses both of these treatments but not together. By using them together, we expect better treatment of melanoma, but there might be an increase in side effects. "Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer. "Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches. The use of combining SRS and Ipilimumab in this research study is investigational. The word "investigational" means that this combination is not approved for marketing by the Food and Drug Administration but is allowed for use in this research study.

NCT ID: NCT01944709 Terminated - Melanoma Clinical Trials

Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Patients With Inoperable Stage III and Stage IV Melanoma

Start date: August 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The prognosis of patients with metastatic melanoma is poor and current available treatments are limited. Identification of a number of melanoma-specific tumor antigens that are shared by tumors from different patients, provides attractive targets for immune-based therapies (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific immune responses. In various animal models and in clinical trials it was shown that the most potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs are professional antigen presenting cells (APC) that are critical in the initiation of cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules needed for the induction of immune responses and have the capacity to migrate into secondary lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides and injected subcutaneously. The concept is to induce or to propagate already existing tumor specific killer T cells.

NCT ID: NCT01942993 Terminated - Melanoma Clinical Trials

The Effects of Treatment With Vemurafenib on the Immune System in Advanced Melanoma

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

Approximately 40-60 % of cutaneous melanomas select for a mutation in a protein called BRAF which is part of a signaling pathway called the Mitogen Activated Protein Kinase (MAPK) pathway. When BRAF is mutated the MAPK pathway remains active allowing for melanoma to grow. Vemurafenib is an oral treatment which blocks the activity of BRAF which leads to decreasing the activity of the MAPK pathway. When patients with melanoma expressing specific mutation in BRAF are treated with vemurafenib approximately 50% will develop a response to treatment with shrinkage of tumor. When compared to a standard chemotherapy called dacarbazine used to treat melanoma, treatment with vemurafenib leads to a statistically significant overall survival or living longer benefit. Because of this survival benefit vemurafenib was Food and Drug Administration (FDA) approved for the treatment of metastatic melanoma expressing a BRAF mutation called V600E BRAF. There is increasing evidence that the immune system can also be important in affecting melanoma growth and survival and there are immune treatments FDA approved for the treatment of metastatic melanoma. There is some limited evidence that blocking BRAF with vemurafenib may affect the activity of components of the immune system. It is important to better characterize and understand the effects of vemurafenib treatment on various components of the immune system. The purpose of this study is to systematically evaluate the effects of vemurafenib treatment (at FDA approved dosing regimen) on parts of the immune systems called the innate and adaptive immune systems. The hypothesis is that vemurafenib treatment will affect the immune system.

NCT ID: NCT01940809 Terminated - Metastatic Melanoma Clinical Trials

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

Start date: August 28, 2013
Phase: Phase 1
Study type: Interventional

This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating melanoma.

NCT ID: NCT01925118 Terminated - Clinical trials for Metastatic Malignant Melanoma and Renal Cell Carcinoma

Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

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

Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.

NCT ID: NCT01918930 Terminated - Melanoma Clinical Trials

Tissue Procurement Substudy for Participants in Study CP-MGA271-01

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

The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

NCT ID: NCT01888081 Terminated - Melanoma Clinical Trials

A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for Treatment of Stage IV Melanoma

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

The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.

NCT ID: NCT01876641 Terminated - Melanoma Clinical Trials

Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

ML28604
Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.

NCT ID: NCT01875653 Terminated - Stage IV Melanoma Clinical Trials

Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug Administration (FDA). This research study will use the patient's own tumor cells,the patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a standard treatment to help increase the number of white blood cells after chemotherapy. The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the growth factor. The resulting solution is called the study therapy. The intent of the study therapy is to make the dendritic cells more effective at fighting the tumor when they are injected back into the patient.