Protocol Number: 02-C-0141
Patients up to 18 years of age with neuroblastoma whose disease does not respond to standard treatment are being enrolled in this study. Candidates are screened with a medical history, physical and neurological examinations, blood and urine tests, electrocardiogram, echocardiogram, and imaging studies. Participants take ABT-751 by mouth daily for 7 days every 21 days for each treatment cycle. Cycles are repeated every 21 to 28 days, depending on how long it takes the patient to recover from the drug side effects. During treatment, patients undergo the following evaluations: -Physical examinations weekly and routine blood tests twice a week during the first four treatment cycle, then periodically during the duration of therapy -MIBG, CT or MRI scans during the first treatment cycle, then before cycles 3 and 5, then every fourth cycle during therapy -Bone marrow biopsy from the pelvic bones on both sides of the body before starting treatment and, if positive for neuroblastoma, repeated periodically during therapy -Echocardiogram before starting treatment, then before cycles 3 and 5, then every fourth cycle during therapy -Daily diary of medications taken each day and record of pain or discomfort for review each cycle -Blood tests during the first treatment cycle to study how the body handles ABT-751. Five blood samples of are drawn on the first day of ABT-751 therapy, one sample is drawn on day 2 before taking the drug, and one sample is drawn between days 3 and 7 before taking the drug. If possible, blood is drawn through a small plastic catheter placed in a vein (heparin lock or Hickman line or port-a-cath) to avoid multiple needle sticks. -Blood draws before starting therapy and at various times during the first treatment cycle for research studies -Magnetic resonance imaging (MRI) with gadolinium contrast before starting the first treatment cycle and again 3 to 7 days after starting treatment to analyze the effect of ABT-751 on blood flow to the tumor. This test is done only in some patients. Patients may continue treatment unless their disease worsens with ABT-751 or they experience unsafe treatment side effects. When they come off the study, they are evaluated with a physical examination, blood and urine tests and tests to assess tumor size.
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