Vorinostat With 131-I MIBG Therapy for Resistant/Relapsed Neuroblastoma: A Phase I Study IND# 105,744

Inclusion Criteria:

- Patients must be at least 24 months and no older than 30 years of age when registered
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 evidence of MIBG uptake into tumor at one site within 4 weeks
prior to entry on study and subsequent to any intervening therapy.

- Patients must have a 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
collection 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, kidney, liver and bone marrow function. Patients
who have bone marrow disease must meet the bone marrow function criteria to enter the
study.

Exclusion Criteria:

- They have had treatment with 131I-MIBG before.

- They have had prior treatment with vorinostat or other HDAC inhibitor.

- 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 bad kidney function.

- They have a history of unexplained blood clot, pulmonary embolus, thrombotic stroke,
or arterial clot.

- They are pregnant or breast feeding.

- They have active infections such as hepatitis or fungal infections.

- They had total body radiation or radiation to the entire belly or a large amount of
radiation to the liver or kidney (some radiation to the liver or kidneys is ok).

- They can't cooperate with the special precautions that are needed during MIBG
treatment.