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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Schering-Plough Eisai 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: | May 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00791271 History of Changes |
Health Authority: | United States: Institutional Review Board |
Melanoma Malignant melanoma Unresectable Decitabine PEG Interferon Alpha-2b |
PEG Interferon Alpha-2b PEG Intron 5-Aza-Deoxycytidine Dacogen |
Antimetabolites Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Interferons Decitabine Angiogenesis Inhibitors Antiviral Agents 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 Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Azacitidine Nevi and Melanomas Growth Inhibitors |
Angiogenesis Modulating Agents Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Enzyme Inhibitors Decitabine Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Peginterferon alfa-2b Interferon Alfa-2a |