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GW572016 to Treat Recurrent Malignant Brain Tumors
NCT00107003 · View on ClinicalTrials.gov ↗
Study Summary
This study will examine whether an experimental drug called GW572016 can delay tumor growth in patients with glioblastoma multiforme (GMB, a malignant brain tumor). GW572016 is believed to affect cancer cell function by interfering with the internal signaling needed for the cancer to grow. The study will also determine whether the presence of specific proteins in the tumor can predict what effects GW572016 will have on the tumor. Patients 18 years of age and older with GMB whose brain tumor does not respond to standard medical treatment and who can undergo surgery for their tumor may be eligible for this study. Candidates are screened with a physical examination and neurocognitive examination, blood tests, electrocardiogram (EKG), echocardiogram (ultrasound test of heart function) or MUGA scan (nuclear medicine test of heart function), magnetic resonance imaging (MRI) of the head, and computed tomography (CT) of the head. CT uses x-rays and MRI uses a magnetic field and radio waves to show brain structure. Participants undergo the following tests and procedures: * MRI and blood tests before surgery. * Surgery to remove the brain tumor. * Follow-up MRIs every 8 weeks after surgery. * Follow-up echocardiograms or MUGA scans every 8 weeks after surgery. * GW572016 treatment starting 7-10 days before surgery and continuing until the patient or doctor decides it is in the patient's best interest to stop it or until the tumor worsens. (The drug is stopped temporarily for surgery and a healing period after surgery.) * Blood tests every 2 weeks to evaluate the effects of GW572016 on the body. * Blood test before the first GW572016 treatment and at the time of surgery to assess the effect of the drug on the cells and to determine how much drug is present in the blood at the time of surgery. Participants are followed in clinic at least monthly while taking GW572016. While on treatment they keep a diary documenting their daily treatments. The diary is collected at the mont
Conditions Studied
Interventions
- DRUG lapatinib ditosylate
- PROCEDURE Adjuvant therapy
- PROCEDURE Conventional surgery
- PROCEDURE Neoadjuvant therapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2005-03-30 |
| Est. Completion | 2012-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00107003
The ClinicalTrials.gov registry entry for NCT00107003 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 4 interventions — of which lapatinib ditosylate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00107003 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00107003 about?
NCT00107003 is a clinical study titled "GW572016 to Treat Recurrent Malignant Brain Tumors". This study will examine whether an experimental drug called GW572016 can delay tumor growth in patients with glioblastoma multiforme (GMB, a malignant brain tumor). GW572016 is believed to affect cancer cell function by interfering with the internal signaling needed for the cancer to grow. The study...
What is the current status of trial NCT00107003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2005-03-30. Estimated completion is 2012-11-30.
What conditions does trial NCT00107003 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Glioma, Brain Tumor, Gliosarcoma, GBM. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00107003?
The interventions under investigation include: lapatinib ditosylate (DRUG), Adjuvant therapy (PROCEDURE), Conventional surgery (PROCEDURE), Neoadjuvant therapy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00107003?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00107003 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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