Spots Global Cancer Trial Database for Study of NS-9 in Patients With Liver Metastases

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Trial Identification

Brief Title: Study of NS-9 in Patients With Liver Metastases

Official Title: A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers

Study ID: NCT00094003

Conditions

Liver Neoplasms

Neoplasm Metastasis

Local Neoplasm Recurrences

Interventions

NS-9 [Poly I: Poly C]

Study Description

Brief Summary: This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.

Detailed Description: This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy. After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.