Calendario›TCRT›ZIO-101

ZIO-101

A Phase I Trial of ZIO-101 in Hematologic Cancers

Ensayo de Alaunos Therapeutics, Inc. en Acute Leukemia · Chronic Myeloproliferative Disease · Chronic Lymphoproliferative Disease · Multiple Myeloma · Lymphoma · Poor-risk Myelodysplasia (MDS) (del registro, en inglés).

Más ensayos de: Mieloma múltiple · Linfoma.

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

1

Fin del objetivo primario

jun 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2005.

Qué mide

Response Rate (del registro, en inglés) (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies. This study is designed to determine whether ZIO-101 may be given safely. The study will also test whether ZIO-101 helps to treat blood cancer. We anticipate that approximately 22 to 35 patients will take part in this study. Arsenic has been used as a medicinal agent for centuries in many different cultures. Most recently in the United States, an inorganic arsenic compound was approved by the FDA for the treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most notably of the cardiac system. ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the NCI human cancer cell panel also detected activity against lung, colon and brain cancers, melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species in the cells to induce apoptosis and cell cycle arrest.

Más ensayos de TCRT

Todos los de TCRT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00592046), actualizada en jul 2012.