Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |