NCT00886457

5-aza-2-deoxycytidine With Pegylated Interferon-alfa 2B: A Phase I Study With Molecular Correlates

Inhibition of DNA Methylation by 1-hr Infusion of 5-aza-2'-Deoxycytidine (Decitabine) x 10 Days (M-F) With Escalating Doses of Sub-Q Pegylated (PEG) Interferon-alfa 2B (PEG-Intron): A Phase I Study With Molecular Correlates

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Nevada Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Decitabine and Pegylated Interferon-Alfa 2B	Patients will receive decitabine 3.7 mg/m2/day i.v. over 1 hour daily in 10 doses over 2 weeks elapsed time (Monday-Friday) every 28 days plus fixed dose of PEG-Intron (0, 0.5, 1.5, 3 or 6 mcg/kg PEG-Intron) weekly by subcutaneous injection in 28-day cycles .

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-08-01
• Completion: 2010-10-01
• First posted: 2009-04-23
• Last updated: 2011-07-20

Locations

1 site across 1 country: United States