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

NCT00886457 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2011-07-20

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Schering-Plough

    collaborator INDUSTRY

  • Nevada Cancer Institute

    lead OTHER

Principal Investigators

  • Wolfram Samlowski, MD · Nevada Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-08-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00886457 on ClinicalTrials.gov