A Pilot Study of the Addition of Bevacizumab to Vincristine, Oral Irinotecan, and Temozolomide (VOIT Regimen) for Relapsed/Refractory Pediatric Solid Tumors
A recent Children's Oncology Group study evaluated the 3-drug combination of vincristine,
oral irinotecan, and temozolomide (VOIT), and found it to be safe and tolerable in pediatric
patients. This VOIT regimen may be useful for a variety of childhood cancers.
Additional data suggests that the beneficial effects of irinotecan can be improved by giving
it with bevacizumab. Bevacizumab is a monoclonal antibody that works against a protein
called "vascular endothelial growth factor" (VEGF). In cancer treatment, it is used to
reduce tumor growth by blocking the formation of new blood vessels.
All of the drugs used in this study have been approved by the Food and Drug Administration
(FDA) for use in adults with certain cancer types. However, the combination of drugs in this
study is considered experimental because the FDA has not approved them to be used together.
Each drug has been given by itself to children before, and the combination of temozolomide,
irinotecan, and vincristine has been given to children in more than one clinical trial. This
is the first study in which all four of the drugs (vincristine, oral irinotecan,
temozolomide, and bevacizumab) will be given together to children.
Up to 20 pediatric patients will receive therapy. The previously established bevacizumab
dose of 15 mg/kg will be administered by intravenous infusion on day 1 at the start of every
3-week course. Intravenous vincristine will be given on day 1, oral irinotecan on days 1-5,
and oral temozolomide on days 1-5. Courses will be repeated as frequently as every three
weeks in patients who do not have evidence of disease progression and who have adequate
recovery from previous courses. Cephalosporin antibiotics will be used to reduce
Patients will be monitored on the study for toxicity and response for up to 6 courses.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Define the toxicities of adding bevacizumab to the established VOIT regimen using cefixime to reduce irinotecan-associated diarrhea.
Brian Turpin, D.O.
Children's Hospital Medical Center, Cincinnati
United States: Institutional Review Board
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|