A Phase 2a Study of Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
1 Year
30 Years
Both
Neuroblastoma
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 Philadelphia | Philadelphia, Pennsylvania 19104 |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
| Childrens Hospital Los Angeles | Los Angeles, California 90027 |
| 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 |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
| University of Chicago Comer Children's Hospital | Chicago, Illinois 60637 |
| Texas Children's Hospital | Houston, Texas |
