At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme
In Brief
A Phase 2 clinical trial evaluating Capecitabine, Celecoxib (Celebrex), and 3 other interventions for Anaplastic Glioma of Brain and 2 related conditions. Completed, enrolled 75 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
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.
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.
Arms 1,3 = 150 mg/m\^2 PO Daily On Day 4-8.
Arms 2,3 = 100 mg/m\^2 PO on Day 4.
Arms 1,2,3 = 80 mg/m\^2 PO Every 6 Hours on Day 1-3.