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Autologous Dendritic Cell-Tumor…

Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma

Ensayo de LISATA THERAPEUTICS, INC. en melanoma estadio IV · melanoma estadio III.

Fase

Fase 3

Estado

Interrumpido

Participantes

4

previstos

Centros

18

Fin del objetivo primario

ene 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2014.

Qué mide

Supervivencia global (52 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

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Ficha completa en ClinicalTrials.gov (NCT01875653), actualizada en may 2019.