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NCT00590681 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT00590681 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 62 participants.
The verdict
NCT00590681, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin. Avastin is the experimental drug being administered in this research study. Avastin binds a protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and circulates in the blood. One of VEGF's main roles is to support the growth of new blood vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from functioning. In laboratory studies, Avastin prevented the growth of several different types of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy. Avastin has not been approved by the FDA for the treatment of GBM and is, therefore, considered experimental. Avastin is currently undergoing testing (alone and in combination with another anti-cancer drug, irinotecan) in persons with GBM that have come back after conventional treatment. Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of cells (including cancer cells) by stopping their division. Temozolomide was approved by the U.S. FDA for the treatment of newly diagnosed GBM in 2005. Avastin and temozolomide are currently being used together in several research studies involving people with newly diagnosed GBM. Limited information is available about either the safety or effectiveness of this drug combination.
Interventions
- DRUG Bevacizumab and Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2007-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590681
The ClinicalTrials.gov registry entry for NCT00590681 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bevacizumab and Temozolomide is the first listed.
NCT00590681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00590681 about?
NCT00590681 is a clinical study titled "Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme". This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by...
What is the current status of trial NCT00590681?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2007-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00590681?
The interventions under investigation include: Bevacizumab and Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00590681?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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