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.

Lead Sponsor:

New Approaches to Neuroblastoma Therapy Consortium

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: Vorinostat
  • Radiation: 131- I Metaiodobenzylguanidine
  • Procedure: Peripheral Blood Stem Cell Infusion
  • Drug: Filgrastim

Phase:

Phase 1

Eligibility


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.

Ages Eligible for Study

2 Years - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting