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Melanoma clinical trials

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NCT ID: NCT01469455 Completed - Clinical trials for Local Metastatic Melanoma

DNA Repair Inhibitor & Irradiation on Melanoma

DRIIM
Start date: October 2011
Phase: Phase 1
Study type: Interventional

Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation. DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design. The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.

NCT ID: NCT01462773 Completed - Melanoma Clinical Trials

Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma

Start date: January 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and dose limiting toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.

NCT ID: NCT01460875 Completed - Clinical trials for Stage IV Skin Melanoma

Recombinant Interferon Alfa-2b in Treating Patients With Melanoma

Start date: April 22, 2008
Phase: N/A
Study type: Interventional

This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma

NCT ID: NCT01460810 Completed - Choroidal Melanoma Clinical Trials

Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma

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

A prospective, experimental, case series of 20 patients, with choroidal melanoma, in which pars plana vitrectomy and Silicone oil as vitreous substitute will be used as intraocular shielding for attenuating the deleterious effects of radiation dose delivered to healthy ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment can reduce the incidence and severity of radiation-induced adverse effects like radiation retinopathy and permanent loss of vision.

NCT ID: NCT01460134 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.

NCT ID: NCT01456104 Completed - Melanoma Clinical Trials

Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma

Start date: October 17, 2011
Phase: Phase 1
Study type: Interventional

This study is being done to see if the investigators can help the immune system to work against melanoma. A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the antigens with dendritic cells to make a vaccine. The investigators think that the body's T cells might then react against the tumor and help destroy it. This study will see if altered dendritic cells will make T cells work against tumor cells. The dendritic cells will be made in a lab and will carry the antigens. These cells then will be injected under the skin. In this study, the investigators are trying to help the body make a stronger immune response against the cancer. The patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. The dendritic cells will contain messenger-RNA (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a laboratory method called electroporation. The mRNA is never given to the patient directly. This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses. The dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.

NCT ID: NCT01455259 Completed - Malignant Melanoma Clinical Trials

Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors

Start date: September 2011
Phase: Phase 1/Phase 2
Study type: Interventional

In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide.

NCT ID: NCT01449279 Completed - Melanoma Clinical Trials

Pilot Ipilimumab in Stage IV Melanoma Receiving Palliative Radiation Therapy

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

To determine the safety of local palliative radiation therapy used in combination with anti-CTLA-4 immunotherapy.

NCT ID: NCT01444560 Completed - Cutaneous Melanoma Clinical Trials

miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi

Start date: December 2008
Phase: N/A
Study type: Observational

MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of miRNA machinery components such as miRNA maturation and transport factors, microprocessor complex and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.

NCT ID: NCT01436656 Completed - Clinical trials for Melanoma and Metastatic Colorectal Cancer

A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

Start date: September 5, 2011
Phase: Phase 1
Study type: Interventional

CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.