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N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma
Not Recruiting
Trial ID: NCT00885326,29,26500,45600
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Zoledronic acid may stop the growth of tumor
cells in bone. Giving bevacizumab together with cyclophosphamide and zoledronic acid may kill
more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving bevacizumab together with
cyclophosphamide and zoledronic acid in treating patients with recurrent or refractory
high-risk neuroblastoma.
Official Title
A Phase I Study of Bevacizumab With Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children With Recurrent or Refractory Neuroblastoma
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients must be no more 30 years of age when enrolled on study.
- Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than
a partial response to standard treatment or persistent neuroblastoma that had at least
a partial response to standard treatment.
- Patients who have at least a partial response to standard treatment who still have
neuroblastoma that can be seen on CT/MRI or MIBG scans must have a surgical biopsy
done of the tumor to confirm that it is neuroblastoma. Patients with relapsed or
refractory neuroblastoma do not need to have a biopsy done to enter on study.
- Patients must have adequate heart, kidney, liver blood clotting and bone marrow
function. Patients who have bone marrow disease must meet the bone marrow function
criteria to enter the study.
- Patients must have recovered from all prior chemotherapy and surgical procedures
Exclusion Criteria:
- They are known to be sensitive to Bevacizumab.
- They have a history of very high blood pressure which required intensive intervention
- They are pregnant or breastfeeding
- Neuroblastoma is present in the brain on a CT or MRI scan done at study entry.
Patients with neuroblastoma found in the bones of the skull are eligible if there is
no tumor mass associated with them pressing on the brain.
- They have a history non healing wounds
Intervention(s):
drug: Bevacizumab
drug: cyclophosphamide
drug: zoledronic acid
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pediatric Hematology/Oncology
650-723-5535