drugset / Trial / NCT00691210

Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

NCT00691210

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.

Timeline

Start
2008-06
Primary completion
2014-02
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoposide Small molecule 25 mg/m2 Intravenous
Subject Etoposide Small molecule 50 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Nicotinamide Other / unclassified 20 mg/kg Oral
Subject Nicotinamide Other / unclassified 40 mg/kg Oral
Subject Nicotinamide Other / unclassified 60 mg/kg Oral
Subject Nicotinamide Other / unclassified 80 mg/kg Oral
Subject Nicotinamide Other / unclassified 100 mg/kg Oral
Subject Vorinostat Small molecule 400 mg Oral