drugset / Trial / NCT00886457
5-aza-2-deoxycytidine With Pegylated Interferon-alfa 2B: A Phase I Study With Molecular Correlates
Phase 1
Terminated
3 enrolled
Nevada Cancer Institute
National Institutes of Health (NIH) · collabSchering-Plough · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess toxicities of a 1-hr infusion of 5-aza-2'-deoxycytidine (decitabine) x 10 days (M-F) plus escalating doses of weekly subcutaneous PEG-interferon-α (PEG-Intron) in patients with metastatic cancer and to identify the maximum tolerated dose of PEG-Intron in this combination. The pre- and post-treatment samples will be evaluated to identify changes in molecular correlates.
Timeline
- Start
- 2009-04
- Primary completion
- 2010-08
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 0 ug/kg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 0.5 ug/kg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 6 ug/kg | Subcutaneous |
| Background | Decitabine | Small molecule | 3.7 mg/m2 | Intravenous |