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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | 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 of Brain Glioblastoma Multiforme Brain Cancer |
Drug: Capecitabine Drug: Celecoxib (Celebrex) Drug: Temozolomide Drug: Lomustine Drug: 6-Thioguanine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme |
| Enrollment: | 75 |
| Study Start Date: | September 2003 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1: Anaplastic Tumors
Anaplastic Tumors - 6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8, after 6 day rest Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours Day 14-27 for 28 day course.
|
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.
Other Name: Xeloda
Drug: Celecoxib (Celebrex)
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.
Other Name: Celebrex
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Other Names:
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
Other Names:
|
|
Active Comparator: 2: Anaplastic Tumors
Anaplastic Tumors - 6-TG 80 mg/m^2 PO every 6 hours Day 1-3, Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 PO every 12 hours Days 11-24, and Celebrex 400 mg PO every 12 hours Days 11-24. Participants if previously received Temozolomide but not Lomustine (CCNU) will receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) will receive Temozolomide. |
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.
Other Name: Xeloda
Drug: Celecoxib (Celebrex)
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.
Other Name: Celebrex
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Other Name: CCNU
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
Other Names:
|
|
Active Comparator: 3: Glioblastoma Multiforme
Glioblastoma Multiforme - 6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle. Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide. |
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.
Other Name: Xeloda
Drug: Celecoxib (Celebrex)
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.
Other Name: Celebrex
Drug: Temozolomide
Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8.
Other Names:
Drug: Lomustine
Arms 2,3 = 100 mg/m^2 PO on Day 4.
Other Name: CCNU
Drug: 6-Thioguanine
Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3.
Other Names:
|
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 | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Charles Conrad, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00504660 History of Changes |
| Other Study ID Numbers: | 2003-0600 |
| Study First Received: | July 18, 2007 |
| Results First Received: | December 6, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Anaplastic Glioma Glioblastoma Multiforme Brain Cancer 6-Thioguanine Capecitabine Celecoxib |
Temozolomide Xeloda Temodar TMZ CCNU 6-TG |
|
Brain Neoplasms Glioblastoma Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lomustine Temozolomide Dacarbazine Capecitabine Thioguanine Fluorouracil Celecoxib Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |