Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Neoplasm Metastasis

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Patients will receive WBRT after local treatment. A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation

A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation

WBRT

Gerald Fogarty, BSc, MBBS

People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

Trans Tasman Radiation Oncology Group

University of Oxford

Melanoma and Skin Cancer Trials Limited

All Drugs and Chemicals

Vaccines

Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells

Dendritic cell vaccination

Anna Karolina Palucka, MD, PhD

The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.

A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Thus, the strategy for this clinical trial will be to test recent laboratory findings in the clinical setting. An additional objective of the study will be to determine the effectiveness of a frozen vaccine product which differs from previous vaccines that were manufactured "fresh".

This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 30 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the vaccine preparation and the rate of objective clinical response. A 15% objective response rate will be accepted in patients who have failed previous therapy with IL-2 and/or dacarbazine (DTIC) and/or temozolomide which are standard treatments for patients with malignant melanoma.

Each subject will be given 7 initial injections in a fixed dose amount. The first 4 doses will be given at 2-week intervals (Weeks 0, 2, 4 and 6); the last 3 doses will be given at 4-week intervals (Weeks 10, 14, and 18). Those patients who exhibit stable disease, partial response or complete response after 7 injections will be given 4 more vaccinations. Each of these additional 4 vaccinations will be given 3 months apart (Weeks 36, 48, 72 and 96). Scans and re-staging tests will be performed at scheduled intervals throughout the study.

Vaccination of Patients With Stage IV Melanoma With Dendritic Cells

Vaccination of Patients With Stage IV Melanoma With Dendritic Cells Generated Ex Vivo From Monocytes and Loaded With Heat Treated Killed Allogeneic Melanoma Cells

Mary Crowley Medical Research Center

ODC Therapy

Baylor Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma	NCT01503827	Metastatic Mela...	WBRT	18 Years -	Melanoma and Skin Cancer Trials Limited
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells	NCT00125749	Melanoma Neoplasm Metast...	Dendritic cell ...	21 Years - 75 Years	Baylor Research Institute
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells	NCT00125749	Melanoma Neoplasm Metast...	Dendritic cell ...	21 Years - 75 Years	Baylor Research Institute

Spots Global Cancer Trial Database for stage iv metastatic melanoma