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A Phase 2a Study of Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma


Phase 2
1 Year
30 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

A Phase 2a Study of Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma


OBJECTIVES:

Primary

- To establish the maximum tolerated dose of iodine I 131 metaiodobenzylguanidine
(^131I-MIBG) in patients with relapsed/refractory high-risk neuroblastoma.

Secondary

- To describe toxicity following treatment with ^131I-MIBG in patients with
relapsed/refractory high-risk neuroblastoma.

- To estimate radiation absorbed doses to measurable lesions and to a standard set of
normal organs following a 0.1 mCi/kg [3.7 MBq/kg] (minimum dose of 1.0 mCi [37 MBq] but
not to exceed 5.0 mCi [185 MBq]) intravenous administration of ^131I-MIBG in patients
with relapsed/refractory high-risk neuroblastoma.

- To describe, within the confines of a phase IIa trial, objective tumor response
following treatment with ^131I-MIBG in patients with relapsed/refractory high-risk
neuroblastoma.

- To explore dose-response following treatment with ^131I-MIBG in patients with
relapsed/refractory high-risk neuroblastoma.

- To explore quality of life assessment following treatment with ^131I-MIBG in patients
with relapsed/refractory high-risk neuroblastoma.

OUTLINE:

- Dosimetry: Patients receive a dosimetric dose of iodine I 131 metaiodobenzylguanidine
(^131I-MIBG) IV over 1-3 minutes. Patients then undergo 2 or 3 MIBG scans within 5 days
of the dosimetry dose to assess biodistribution and tumor uptake. Patients with normal
tumor uptake and biodistribution proceed to treatment.

- Treatment: Within 1-4 weeks of the dosimetric dose, patients with normal tumor uptake
and biodistribution receive a therapeutic dose of ^131I-MIBG IV over 1 hour on day 0
and undergo MIBG scan on day 7. Patients then proceed to autologous stem cell infusion.

- Autologous stem cell infusion: Patients receive an infusion of autologous stem cells
from peripheral blood or bone marrow on day 14. Patients with an ANC of < 500/µl at any
point after autologous stem cell infusion receive filgrastim (G-CSF) IV or
subcutaneously once daily until ANC is > 2,000/µl.

Patients complete a quality of life questionnaire at baseline and then at day 60.

After completion of study treatment, patients are followed at day 60 and periodically
thereafter.


Inclusion Criteria:



- Patients must be at least one year and no more than 30 years of age when registered
on this study.

- Patients must have high risk neuroblastoma and either have tumor left after treatment
started at diagnosis or have had the tumor grow back (relapsed) after getting some
treatment

- Patients must an MIBG scan done and it must be positive for neuroblastoma.

- Patients must have a PBSC or bone marrow stem cell product available that meets study
criteria. If they don't already have stem cells frozen away then they must be able
to have a stem cell pheresis done to collect the necessary amount of stem cells for
study entry and these stem cells must meet study criteria.

- Patients must have adequate heart, lung, liver, kidney and bone marrow function.

Exclusion Criteria:

- They have had a stem cell transplant using another person as the stem cell donor.
(You can still be in the study if a previous transplant used your own stem cells)

- They have other medical problems that could get much worse if they had this
treatment.

- They are on dialysis for badly working kidneys or have other kidney problems.

- They are pregnant or breast feeding.

- They have tumor in the brain or spinal cord that is seen on a CT or MRI scan one
month before starting treatment

- They had total body radiation or radiation to the entire belly.

- They have a known allergy to MIBG, iodine or SSKI.

- They can't cooperate with the special precautions that are needed during UltratraceTM
MIBG treatment or with other safety monitoring requirements of the study..

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Description:

Dose limiting toxicity (DLT) is defined as any of the events (defined in Section 4.4 of the protocol) that are (possibly, probably or definitely) attributable to UltratraceTM iobenquane I 131. The MTD will be the highest dose tested at which fewer than one third of patients experience DLT when 6 patients have been treated at the MTD. If 6 patients are treated at the highest Dose Level, 4, and fewer than 2 patients experience a DLT, then the MTD will not be reached.

Outcome Time Frame:

Each patient in a Dose Level cohort must be followed until time of DLT, to day 60 +/- 10 days or until engraftment which ever comes first before escalating to the next dose level

Safety Issue:

Yes

Principal Investigator

Katherine K. Matthay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000593357

NCT ID:

NCT00659984

Start Date:

March 2008

Completion Date:

November 2010

Related Keywords:

  • Neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Childrens Hospital Los AngelesLos Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
University of Chicago Comer Children's HospitalChicago, Illinois  60637
Texas Children's HospitalHouston, Texas