Status:
COMPLETED
N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma
Lead Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * To determine the toxicities and feasibility of bolus and metronomic cyclophosphamide when given in combination with zoledronic acid with and without bevacizumab in patients wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00885326
Start Date
December 1 2009
End Date
December 1 2019
Last Update
April 10 2023
Active Locations (15)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
2
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322