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| Sponsored by: |
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:
Patients who received only Temozolomide during radiation therapy and did not receive adjuvant chemotherapy with Temozolomide and/or those who received Gliadel (BCNU) wafers at surgery without adjuvant chemotherapy with BCNU or CCNU are eligible if 6 months has passed since the treatment(s).
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 |
|
Antimetabolites Anti-Inflammatory Agents Glioblastoma Lomustine Central Nervous System Neoplasms Brain Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Analgesics Glioblastoma Multiforme Glioma Alkylating Agents Nervous System Neoplasms Capecitabine |
Celecoxib Astrocytoma Thioguanine Cyclooxygenase Inhibitors Central Nervous System Diseases Temozolomide Recurrence Neuroectodermal Tumors Brain Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Neoplasms, Glandular and Epithelial |
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Anti-Inflammatory Agents Antimetabolites Glioblastoma Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Brain Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Glioma Alkylating Agents Nervous System Neoplasms Capecitabine Neoplasms by Histologic Type Celecoxib Astrocytoma Cyclooxygenase Inhibitors Nervous System Diseases Thioguanine Central Nervous System Diseases Enzyme Inhibitors Temozolomide Pharmacologic Actions |