A Phase I Study of Bevacizumab With Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children With Recurrent or Refractory Neuroblastoma

Status
Active
Cancer Type
Neuroblastoma
Trial Phase
Phase I
Eligibility
30 and under, Male and Female
Study Type
Treatment
NCD ID
NCT00885326
Protocol IDs
CDR0000638257 (primary)
P01CA081403
NANT2007-02
NANT-N2007-02
N2007-02
Study Sponsor
New Approaches to Neuroblastoma Therapy Consortium

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.

Objectives

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.

Treatment Sites in Georgia


Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD
Muna Qayed MD

Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite
5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Dolly Aguilera MD
Tobey J. MacDonald MD