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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525031 |
Purpose
The goal of this clinical research study is to learn if temozolomide alone or given with pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want to study the safety of these 2 treatments.
Objectives:
1) Known cellular and molecular markers of apoptosis and cell proliferation, 2) Promotor methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT), 3) DNA sequence variability of tumor suppressor genes and DNA repair enzymes, 4) Tumor genomic expression profiles analysis by cDNA microarray and protein array
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Temozolomide (TMZ) Drug: Pegylated Interferon Alpha-2b (PGI) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Neoadjuvant Study of Temozolomide Alone or With Pegylated Interferon-alpha 2b in Patients With Resectable AJCC Stage IIIB/IIIC or Stage IV (M1a) Metastatic Melanoma |
| Estimated Enrollment: | 124 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TMZ
Temozolomide = TMZ
|
Drug: Temozolomide (TMZ)
150 mg/m^2 by mouth once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
Other Name: Temodar
|
|
Experimental: TMZ + PGI
Temozolomide = TMZ and PGI = Pegylated Interferon-alpha 2b
|
Drug: Temozolomide (TMZ)
150 mg/m^2 by mouth once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
Other Name: Temodar
Drug: Pegylated Interferon Alpha-2b (PGI)
0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
Other Name: PEG-Intron
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Wen-Jen Hwu, MD PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525031 History of Changes |
| Other Study ID Numbers: | 2005-0143 |
| Study First Received: | August 31, 2007 |
| Last Updated: | October 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Melanoma Temozolomide Temodar Pegylated Interferon Alpha-2b |
PEG-Intron PGI Resectable metastatic melanoma Surgery |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Peginterferon alfa-2b Temozolomide Dacarbazine |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |