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


Phase 1
N/A
30 Years
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

Any dose limiting toxicity (DLT) as defined in section 9.2 of protocol.

Outcome Time Frame:

Study entry, day 14 of course 1, prior to course 2, day 14 of course 2.

Safety Issue:

Yes

Principal Investigator

Julia L. Glade-Bender, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000638257

NCT ID:

NCT00885326

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of Chicago Comer Children's HospitalChicago, Illinois  60637
Children's Hospital BostonBoston, Massachusetts  02115
Duke University Medical CenterDurham, North Carolina  27710
Children's Healthcare of AtlantaAtlanta, Georgia  30342
C.S Mott Children's HospitalAnn Arbor, Michigan  48109