GW572016 to Treat Recurrent Malignant Brain Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00107003
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
  • Adjuvant therapy — PROCEDURE
  • Conventional surgery — PROCEDURE
  • Neoadjuvant therapy — PROCEDURE

Study Details

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.

Key Dates

Start date
Mar 30, 2005
Status verified
Nov 2012
Primary completion
Dec 5, 2007
Completion
Nov 30, 2012

Study Design

Enrollment
9 participants (actual)
Primary purpose
TREATMENT

Primary Outcome Measure

Determine 6-month progression-free survival of patients undergoing surgery for recurrent progressive glioblastoma multiforme or gliosarcoma treated with lapatinib.

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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