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Melanoma clinical trials

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NCT ID: NCT01079741 Completed - Melanoma Clinical Trials

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

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

The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.

NCT ID: NCT01078961 Completed - Melanoma Clinical Trials

An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma

Start date: September 2010
Phase: Phase 1
Study type: Interventional

This research study involves the use of two investigational drugs: sorafenib and bortezomib. Sorafenib is designed to stop the growth of cells caused by changes associated with cancer. Bortezomib is designed to stop cancer cells from getting rid of waste products. This causes the cells to build up toxic levels of waste that leads to cell death. In the laboratory, the combination of sorafenib and bortezomib has been shown to fight cancer cells better than either drug alone. We are looking to determine if the combination of sorafenib and bortezomib is a safe treatment for patients with advanced melanoma. The effectiveness of this combination will also be assessed.

NCT ID: NCT01077050 Completed - Malignant Melanoma Clinical Trials

SciBase International Melanoma Pivotal Study

Start date: April 2010
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference). The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.

NCT ID: NCT01069627 Completed - Malignant Melanoma Clinical Trials

A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

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

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

NCT ID: NCT01066390 Completed - Melanoma Clinical Trials

A Study on the Safety and Immunogenicity of Combined Intradermal and Intravenous Administration of an Autologous mRNA Electroporated Dendritic Cell Vaccine in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Start date: December 2009
Phase: Phase 1
Study type: Interventional

This phase I study plan is divided in the following four phases: - Eligibility Screen Phase (week -4 to -1): Following written informed consent patients with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an eligibility screen (incl. blood analysis and PET/CT-scan). - TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC vaccine. Vaccine preparations will be manufactured and quality-controlled (during an interval of 4 weeks following the leucapheresis) and released for patient administration if the TriMix-DC preparation fulfills the predefined quality requirements. - TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID administration. The vaccines will be administered at 4 different visits that will be separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per antigen will be administered. - Patients will be allocated to three different cohorts: - The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection. - The second cohort 25% by iv and 75% by id injection. - The third cohort 50% by iv and 50% by id injection. - During the week following the administration of the fourth vaccine (= week 8), a DTH-test and punch biopsy of the injection site will be performed as well as a second leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT). - A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (= 8w after the fourth vaccine). - End of study visit: Patients will perform an "end of study visit" 8 weeks after the fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT). - Follow-up Phase: survival data will be obtained until 3 years after the initiation of vaccine therapy or the time of death.

NCT ID: NCT01065467 Completed - Melanoma Clinical Trials

Panobinostat (LBH589) in Patients With Metastatic Melanoma

Start date: February 2010
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to determine the safety of LBH589 as well as to find out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug which may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes, which are proteins normally produced by cells. These enzymes are known to play an important role in the development and reproduction of cancer cells. It is believed that LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in our cells that suppress cells from becoming cancerous.

NCT ID: NCT01065441 Completed - Breast Cancer Clinical Trials

Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer

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

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.

NCT ID: NCT01064713 Completed - Cancer Clinical Trials

Phase II Study of Tesetaxel in Metastatic Melanoma

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

The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.

NCT ID: NCT01053819 Completed - Melanoma Clinical Trials

Can We Miss Pigmented Lesions in Psoriasis Patients?

Start date: September 2007
Phase: Phase 4
Study type: Interventional

In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.

NCT ID: NCT01052142 Completed - Melanoma Clinical Trials

Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.