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NCT00504660 · ClinicalTrials.gov registry record · Phase 2
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
A Phase 2 study of Glioblastoma Multiforme and Brain Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00504660: Completed Phase 2 study of Glioblastoma Multiforme and Brain Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00504660 is a Phase 2 study of Glioblastoma Multiforme and Brain Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 75 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00504660, a Phase 2 study of Glioblastoma Multiforme and Brain Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Temozolomide
- DRUG Lomustine
- DRUG 6-Thioguanine
- DRUG Celecoxib (Celebrex)
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2003-09 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00504660 record still lists
NCT00504660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (22% lower).
The record links to 3 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT00504660 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00504660 about?
NCT00504660 is a clinical study titled "6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients". 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...
What is the current status of trial NCT00504660?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2003-09. Estimated completion is 2010-08.
What conditions does trial NCT00504660 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Brain Cancer, Anaplastic Glioma of Brain.
What interventions are being tested in trial NCT00504660?
The interventions under investigation include: Capecitabine (DRUG), Temozolomide (DRUG), Lomustine (DRUG), 6-Thioguanine (DRUG), Celecoxib (Celebrex) (DRUG).
Who is sponsoring clinical trial NCT00504660?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00504660 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00504660's enrollment target sits among peer trials
75 24th of 88 higher than 65 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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