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NCT00995007 · ClinicalTrials.gov registry record · Phase 2
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
A Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 1
- Study location
NCT00995007: Completed Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by National Cancer Institute (NCI).
NCT00995007 is a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 112 participants, above the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00995007, a Phase 2 study of Glioblastoma Multiforme and Gliosarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors, with needed nutrients and oxygen for cancer cells to survive. One possible treatment for different kinds of cancer involves treatment with drugs that slow or stop angiogenesis and prevent further tumor growth. * Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses. * Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy. Objective: \- To determine the safety and effectiveness of vandetanib and carboplatin, given together or sequentially, against recurrent high-grade gliomas. Eligibility: \- Adults diagnosed with a malignant glioma who have received standard treatments that no longer appear to be effective. Design: * Patients will be assigned to one of two groups. Group 1 patients (combination group) will receive oral vandetanib for 28 days and intravenous (IV) carboplatin (once at the beginning of the 28-day cycle). Group 2 patients (sequential group) will receive IV carboplatin alone (once at the beginning of the 28-day cycle) and then oral vandetanib (300 mg daily) for 28 days if the tumor grows or the patient develops unacceptable carboplatin toxicity. * Treatment will continue in 28-day cycles for 1 year for both groups. * Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, routine laboratory tests, electrocardiograms, and magnetic resonance imaging (MRI) scans * At the end of 1 year of treatment, patients will be reevaluat
Primary Outcome
Percentage of participants who are alive and progression-free at 6 months.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG ZD6474 (Vandetanib)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT00995007 record still lists
NCT00995007 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (17% higher).
The record links to 5 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Carboplatin is the first listed.
NCT00995007 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00995007 about?
NCT00995007 is a clinical study titled "A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas". Background: * Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors, with needed nutrients and oxygen for cancer cells to survive. One possible treatment for different kinds of cancer involves treatment with drugs that slow or stop angiogenesis and prevent further ...
What is the current status of trial NCT00995007?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2009-09. Estimated completion is 2015-12.
What conditions does trial NCT00995007 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Oligoastrocytoma.
What interventions are being tested in trial NCT00995007?
The interventions under investigation include: Carboplatin (DRUG), ZD6474 (Vandetanib) (DRUG).
Who is sponsoring clinical trial NCT00995007?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00995007 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00995007's enrollment target sits among peer trials
112 15th of 88 higher than 74 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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