Trial Search Results
N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
Stanford is currently not accepting patients for this trial.
New Approaches to Neuroblastoma Therapy Consortium
Collaborator: National Cancer Institute (NCI)
- Drug: Vorinostat
- Radiation: 131- I Metaiodobenzylguanidine
- Procedure: Peripheral Blood Stem Cell Infusion
- Drug: Filgrastim
- Patients must be at least 24 months and no older than 30 years of age when registered
- 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
- 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
Ages Eligible for Study
2 Years - 30 Years
Genders Eligible for Study