N2007-02:Bevacizumab,Cyclophosphamide,& Zoledronic Acid in Patients W/ Recurrent or Refractory High-Risk Neuroblastoma
Information source: New Approaches to Neuroblastoma Therapy Consortium
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuroblastoma
Intervention: Bevacizumab (Drug); cyclophosphamide (Drug); zoledronic acid (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: New Approaches to Neuroblastoma Therapy Consortium Official(s) and/or principal investigator(s):
Julia L. Glade-Bender, MD, Principal Investigator, Affiliation: Herbert Irving Comprehensive Cancer Center
Overall contact:
Julia Glade-Bender, MD, Phone: (212) 305-3379, Email: jg589@columbia.edu
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 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.
Clinical Details
Official title: A Phase I Study of Bevacizumab With Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children With Recurrent or Refractory Neuroblastoma
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Evaluation of response within the confines of a phase I study.Analysis of Circulating Endothelial Cells, Circulating Factors, Gene expression and Bone Metabolism Studies.
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
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.
Eligibility
Minimum age: N/A.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Julia Glade-Bender, MD, Phone: (212) 305-3379, Email: jg589@columbia.edu
Children's Hospital Los Angeles, Los Angeles, California 90027-0700, United States; Recruiting
Araz Marachelian, MD, Phone: 323-361-5687, Email: amarachelian@chla.usc.edu
Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California 94304, United States; Recruiting
Clare Twist, MD, Phone: 650-723-5535
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94143, United States; Recruiting
Katherine K. Matthay, MD, Phone: 415-476-3831, Email: matthayk@peds.ucsf.edu
Children's Healthcare of Atlanta, Atlanta, Georgia 30322, United States; Recruiting
Howard Katzenstein, MD, Phone: 404-727-4451, Email: Howard.katzenstein@choa.org
University of Chicago Comer Children's Hospital, Chicago, Illinois 60637, United States; Recruiting
Susan L. Cohn, MD, Phone: 773-702-2571, Email: scohn@peds.bsd.uchicago.edu
Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting
Suzanne Shusterman, MD, Phone: 617-632-4901, Email: suzanne_shusterman@dfci.harvard.edu
C.S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States; Recruiting
Gregory Yanik, MD, Phone: 734-936-8785, Email: gyanik@umich.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Susan Kreissman, MD, Phone: 919-684-3401
Michael Armstrong, MD, Phone: 919-668-9055
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States; Recruiting
Brian Weiss, MD, Phone: 513-636-9863, Email: brian.weiss@chmcc.org
Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Sylvain Baruchel, MD, Phone: 416-813-7795
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-4318, United States; Recruiting
Yael Mosse, MD, Phone: 215-590-0965, Email: mosse@chop.edu
CHU Sainte Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting
Pierre Teira, MD, Phone: 514-345-4870, Email: pierre.teira.hsj@ssss.gouv.qc.ca
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Meaghan Granger, MD, Phone: 682-885-2580, Email: mgranger@cookchildrens.org
Texas Children's Cancer Center, Houston, Texas 77030-2399, United States; Recruiting
Peter Zage, MD, Phone: 832-822-4586, Email: sblaney@txccc.org
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States; Recruiting
Julie R. Park, MD, Phone: 206-987-2106, Email: Julie.park@seattlechildrens.org
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database N07-02 Information on NANT.org
Starting date: December 2009
Last updated: April 26, 2012
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