drugset / Trial / NCT01421173

Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

NCT01421173

Phase 1 Completed 78 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of vorinostat that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant. Researchers also want to learn about the safety and level of effectiveness of this combination. Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan. Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as gemcitabine, busulfan and melphalan.

Timeline

Start
2011-08
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule 200 mg Oral
Background Busulfan Small molecule 105 mg/m2 Intravenous
Background Dexamethasone Small molecule 8 mg Intravenous
Background Gemcitabine Small molecule 2175 mg/m2 Intravenous
Background Melphalan Small molecule 60 mg/m2 Intravenous
Background Palifermin Protein / enzyme biologic 60 ug/kg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications