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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Schering-Plough Eisai Medical Research Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00791271 |
Primary Objectives:
Phase I: To determine the safety and tolerability of the combination of decitabine and peginterferon alfa-2b at 6 pre-determined dose levels in patients with advanced melanoma.
Phase II: To determine the clinical benefit rate (stable disease + partial response + complete response), as measured by RECIST criteria, of patients with advanced melanoma treated with decitabine and peginterferon alfa-2b.
Secondary Objectives:
Condition | Intervention | Phase |
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Melanoma |
Drug: Decitabine Drug: Pegylated Interferon Alpha-2b |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma |
Estimated Enrollment: | 80 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Decitabine + Peginterferon Alfa-2b
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Drug: Decitabine
Starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.
Drug: Pegylated Interferon Alpha-2b
Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wen-Jen Hwu, MD, PhD | 713-792-2921 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Wen-Jen Hwu, MD, PhD 713-792-2921 | |
Principal Investigator: Wen-Jen Hwu, MD, PhD |
Principal Investigator: | Wen-Jen Hwu, MD, PhD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Wen-Jen Hwu, MD, PhD/Professor ) |
Study ID Numbers: | 2007-0450 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00791271 |
Health Authority: | United States: Institutional Review Board |
Melanoma Decitabine PEG Interferon Alpha-2b PEG Interferon Alpha-2b |
PEG Intron 5-Aza-Deoxycytidine Dacogen |
Interferon-alpha Interferon Type I, Recombinant Interferons Decitabine Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Nevus, Pigmented Azacitidine Peginterferon alfa-2b Neuroepithelioma Nevus Interferon Alfa-2a Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents |