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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504660 |
Purpose
The goal of this clinical research study is to learn if the combination of 6-Thioguanine, Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or glioblastoma multiforme in patients who have failed previous treatments. The safety of these combination treatment will also be studied.
Objectives:
1.1 To determine the efficacy, as measured by 12 month progression-free survival, of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma multiforme.
1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme patients treated in this manner.
1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of response to this chemotherapy and long term survival
| 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
|
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
|
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: | January 21, 2010 |
| 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 |