A Pilot Study of the Addition of Bevacizumab to VOIT Regimen for Relapsed/Refractory Pediatric Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to test the safety and of adding bevacizumab to the
      established regimen of vincristine, oral irinotecan, and temozolomide (VOIT) and see what
      effects it has in pediatric patients with relapsed or refractory solid tumors.
    

Detailed description: 
      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
      irinotecan-associated diarrhea.

      Patients will be monitored on the study for toxicity and response for up to 6 courses.
    

Intervention name(s): Bevacizumab; Temozolomide; Vincristine; Irinotecan; Cefixime
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Bevacizumab (IV) 15 mg/Kg on day 1 every 3 weeks for up to 6 cycles; 100 mg/m2/day po on Days 1-5 every 3 weeks for up to 6 cycles. For patients under 0.5 m2 BSA, TEM = 3.3 mg/kg/day po on Days 1-5.; 1.5 mg/m2 on Day 1 (max dose 2 mg) administered as an IV bolus every 3 weeks for up to 6 cycles. For patients <0.5 m2 BSA, VCR dose = 0.05 mg/kg (maximum dose 2 mg).; 90 mg/m2/day po on Days 1-5 every 3 weeks for up to 6 cycles; 8 mg/kg/day (max. daily dose 400 mg) of cefixime or 5 mg/kg/dose bid (max. daily dose 400 mg) of cefpodoxime starting Day -1 BEFORE chemotherapy and continuing EVERY DAY while on study, or for 2 days after last dose of chemotherapy if treatment stopped early for disease progression or toxicity
Other intervention name(s): rhuMAb VEGF; Avastin; Temodar; TEM; VCR; Oncovin; CPT-11; Camptothecin-11; Camptosar®; IRN; Suprax®; Vantin®; Cefpodoxime; CEF
Intervention MeSH terms: Cefixime; Cefpodoxime; Bevacizumab; Irinotecan; Vincristine; Temozolomide; Camptothecin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment