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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504660 |
Purpose
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Glioma Glioblastoma Multiforme Brain Cancer |
Drug: Capecitabine Drug: Celecoxib Drug: Temozolomide Drug: Lomustine Drug: 6-Thioguanine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme |
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Anaplastic Tumors: Active Comparator
Anaplastic Tumors - 6-TG, Temozolomide, Capecitabine and Celebrex
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Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
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2: Anaplastic Tumors: Active Comparator
Anaplastic Tumors - 6-TG, Lomustine, Capecitabine and Celebrex
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Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
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3: Glioblastoma Multiforme: Active Comparator
Glioblastoma Multiforme - 6-TG, Temozolomide, Capecitabine and Celebrex or 6-TG, Lomustine, Capecitabine and Celebrex
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Drug: Capecitabine
Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24.
Drug: Celecoxib
Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Victor Levin, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Victor Levin, MD/Professor ) |
| Study ID Numbers: | 2003-0600 |
| Study First Received: | July 18, 2007 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00504660 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anaplastic Glioma Glioblastoma Multiforme Brain Cancer 6-Thioguanine Capecitabine Celecoxib |
Temozolomide Xeloda Temodar TMZ CCNU 6-TG |
|
Anti-Inflammatory Agents Antimetabolites Glioblastoma Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Lomustine Central Nervous System Neoplasms 6-Mercaptopurine Brain Diseases Neoplasms by Site Sensory System Agents |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Anti-Inflammatory Agents, Non-Steroidal Analgesics Glioma Alkylating Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Capecitabine Neoplasms by Histologic Type Celecoxib Astrocytoma Cyclooxygenase Inhibitors Nervous System Diseases Thioguanine |