N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma
NCT ID: NCT00885326
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2009-12-31
2019-12-31
Brief Summary
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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.
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Detailed Description
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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 with recurrent or refractory high-risk neuroblastoma.
Secondary
* To preliminarily evaluate the antitumor activity of this regimen in these patients within the confines of a pilot study.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1 hour and zoledronic acid IV over 15 minutes on day 0 and oral cyclophosphamide once daily on days 1-27 in course 1. In course 2 and all subsequent courses, patients receive bevacizumab IV over 30-90 minutes on days 0 and 14, cyclophosphamide IV over 1 hour and zoledronic acid IV over 15 minutes on day 1, and oral cyclophosphamide once daily on days 0 and 2-27. Treatment repeats every 28 days for up to 2 years\* in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients may receive up to 13 doses of zoledronic acid.
After completion of study treatment, patients are followed periodically.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Bevacizumab: Every course will be 28 days. Bevacizumab 10 mg/kg/dose , will be administered intravenously every 14 days beginning on day 0 of the second course.
Cyclophosphamide will be administered as an intravenous (IV) bolus according to the protocol assigned dose level followed by daily oral dosing (25mg/m2/day) without interruption (unless toxicity supervenes).
Zoledronic acid will be administered on day 0 of course 1 and day 1 of course 2 and all subsequent courses in a dose of 4mg/m2 (max 4 mg per dose). On days when zoledronic acid (ZA) and cyclophosphamide (CTX) are given together, CTX should be given first.
Bevacizumab
Every course will be 28 days. Bevacizumab 10 mg/kg/dose , will be administered intravenously every 14 days beginning on day 0 of the second course.
cyclophosphamide
Cyclophosphamide will be administered as an intravenous (IV) bolus according to the protocol assigned dose level followed by daily oral dosing (25mg/m2/day) without interruption (unless toxicity supervenes).
zoledronic acid
Administered on day 0 of course 1 and day 1 of course 2 and all subsequent courses in a dose of 4mg/m2 (max 4 mg per dose). On days when zoledronic acid (ZA) and cyclophosphamide (CTX) are given together, CTX should be given first.
Interventions
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Bevacizumab
Every course will be 28 days. Bevacizumab 10 mg/kg/dose , will be administered intravenously every 14 days beginning on day 0 of the second course.
cyclophosphamide
Cyclophosphamide will be administered as an intravenous (IV) bolus according to the protocol assigned dose level followed by daily oral dosing (25mg/m2/day) without interruption (unless toxicity supervenes).
zoledronic acid
Administered on day 0 of course 1 and day 1 of course 2 and all subsequent courses in a dose of 4mg/m2 (max 4 mg per dose). On days when zoledronic acid (ZA) and cyclophosphamide (CTX) are given together, CTX should be given first.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
New Approaches to Neuroblastoma Therapy Consortium
OTHER
Responsible Party
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Principal Investigators
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Julia L. Glade-Bender, MD
Role: PRINCIPAL_INVESTIGATOR
Herbert Irving Comprehensive Cancer Center
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States
Children's Hospital Boston
Boston, Massachusetts, United States
C.S Mott Children's Hospital
Ann Arbor, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Texas Children's Cancer Center
Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte Justine
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CDR0000638257
Identifier Type: -
Identifier Source: org_study_id
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