A Phase I Study of Bevacizumab With Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children With Recurrent or Refractory Neuroblastoma
- 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.
- 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of toxicities and feasibility of the combination of bolus plus metronomic cyclophosphamide and zoledronic acid with and without bevacizumab when given to children with refractory or recurrent high risk neuroblastoma.
Any dose limiting toxicity (DLT) as defined in section 9.2 of protocol.
Study entry, day 14 of course 1, prior to course 2, day 14 of course 2.
Julia L. Glade-Bender, MD
Herbert Irving Comprehensive Cancer Center
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|Texas Children's Cancer Center||Houston, Texas 77030-2399|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Lucile Packard Children's Hospital at Stanford University Medical Center||Palo Alto, California 95798|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|University of Chicago Comer Children's Hospital||Chicago, Illinois 60637|
|Children's Hospital Boston||Boston, Massachusetts 02115|
|Duke University Medical Center||Durham, North Carolina 27710|
|Children's Healthcare of Atlanta||Atlanta, Georgia 30342|
|C.S Mott Children's Hospital||Ann Arbor, Michigan 48109|