Clinical Trials

Study : NANT 2007-01

Ultratrace^TM-MIBG for High Risk Neuroblastoma

Protocol Title: A Phase 2a Study of Ultratrace^TM Iobenguane I 131 in Patients with Relapsed/Refractory High-Risk Neuroblastoma

Study Chair: Katherine K Matthay, MD. (University of California-San Francisco)

What is this study about:

This study will use an experimental form of MIBG called Ultratrace^TM Iobenguane I 131 (Ultratrace^TM). Ultratrace^TM is made in a different way compared to other forms of MIBG. The Ultratrace^TM form of MIBG has radioactive iodine attached to 20 times more MIBG molecules than the "standard" form of MIBG. This means more radioactive MIBG molecules may be given in treatment with Ultratrace^TM which may kill more neuroblastoma cells. Ultratrace^TM MIBG lowers the number of blood forming cells (called stem cells) in the bone marrow when it is given at higher doses. All patients will get back their own stem cells since it is expected that as the dose of Ultratrace^TM MIBG is increased, the blood cells will not recover to normal without giving this support. This study will be the first study to test giving Ultratrace^TM MIBG in children and will help determine the highest Ultratrace^TM MIBG dose that can be given safely to patients with resistant/relapsed neuroblastoma.

Why is this study being done:

This study is being done to try and answer the following questions:

To find the highest dose of a new form of MIBG, Ultratrace^TM Iobenguane I 131, that can be given by vein without causing severe side effects.
To find out the side effects of Ultratrace^TM Iobenguane I 131 given on this schedule at different dose levels.
To measure how much radiation is taken up by tumors seen on a CT or MRI scan and different tissues/organs in the body after a small dose of Ultratrace^TM Iobenguane I 131 is given by vein.
To determine if your tumor gets smaller after treatment with Ultratrace^TM Iobenguane I 131.
To find out about how treatment with Ultratrace^TM Iobenguane I 131 affects your quality of life at about two months after you are treated.

Criteria that need to be met to participate in this study:

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.

Patients cannot participate in the study if:

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 Ultratrace^TM MIBG treatment or with other safety monitoring requirements of the study.

Study procedures:

(Please click on the table above to view a larger version.)

This study is done in two parts called Dosimetry and Treatment. Dosimetry and administration of the Ultratrace^TM treatment dose will be done at the designated NANT MIBG treatment centers for this study. The stem cell infusion and end of treatment evaluation may be done at any hospital that is a part of NANT.

You will be treated once with Ultratrace^TM MIBG.

Ultratrace^TM MIBG dosimetry and treatment are done at a hospital that is set up to take care of patients that are treated with radioactive substances. For this study, these hospitals are located in San Francisco, CA, Philadelphia, PA, Ann Arbor, MI and Cincinnati, OH. Ultratrace^TM MIBG treatment is given by IV over 30-60 minutes. Patients who get MIBG are considered to be "hot' or radioactive and special precautions are taken to care for you during this time until the radiation has gone down to a level where these precautions are no longer needed. You are in your own room and the time family members can be in the room with you is limited at first but will increase every day as the radiation level goes down.

All patients/parents/legal guardians will complete a Quality of life questionnaire once before starting dosimetry and again at end of treatment with Ultratrace^TM for all patients. Children 5 years and older will also answer their own questionnaire. You will answer questions about how you feel and what activities you are able to do. This will take about 10 minutes. Researchers want to see if treatment with Ultratrace^TM has any effect on your quality of life.

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