GW572016 to Treat Recurrent Malignant Brain Tumors
Status:
Completed
Trial end date:
2012-11-30
Target enrollment:
Participant gender:
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
monthly follow-up exams. After the treatment ends, patients are contacted periodically by the
research staff for the rest of their lives to follow the long-term effects of the study.