Spots Global Cancer Trial Database for A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

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Trial Identification

Brief Title: A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

Official Title: Phase I Trial of Oral 5-azacitidine With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

Study ID: NCT01537744

Conditions

Solid Tumors

Virally Mediated Cancers and Liposarcoma

Interventions

oral 5-azacitidine in combination with romidepsin

Study Description

Brief Summary: The purpose of this study is to determine whether 5-azacitidine in combination with romidepsin cancer are effective in the treatment of advanced solid tumors.

Detailed Description: This is a two part, single-institution, open-label, Phase I dose-escalation study of oral 5-azacitidine in combination with intravenous (IV) romidepsin. Part 1 of the study is a traditional 3 + 3 dose escalation study designed to evaluate the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), safety, pharmacokinetic (PK) profiles, and pharmacodynamic profiles of increasing doses of orally administered 5-azacitidine in combination with a constant dose of IV romidepsin. Part 2 is an expansion cohort study for the preliminary evaluation of efficacy in the treatment of virally mediated cancers and liposarcoma once the MTD has been determined. PK and PD data will also be collected for these subjects. * Plasma samples will be obtained, prior and during treatment, to assess the methylation status of free tumor DNA circulating in the blood * Archival tissue will be obtained on all participants for future correlative studies, such as baseline gene expression, methylation patterns. * Participants with accessible, biopsiable tumors will also undergo pre-treatment and post-treatment (\~cycle 2D1) biopsies for correlative studies in the expansion cohort.