N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma

Completed · Phase 1

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID: NCT01019850
Run by: New Approaches to Neuroblastoma Therapy Consortium
People needed: 27
Starts: 2010-03-01
Expected to finish: 2015-02-01
Last updated by the study team: 2023-04-10

Who can join

Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Children's Hospital Los Angeles — Los Angeles, California, United States
Lucile Salter Packer Children's Hospital — Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus — Atlanta, Georgia, United States
University of Chicago, Comer Children's Hospital — Chicago, Illinois, United States
Children's Hospital Boston — Boston, Massachusetts, United States
C.S Mott Children's Hospital — Ann Arbor, Michigan, United States
Duke University Medical Center — Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Cook Children's Medical Center - Fort Worth — Fort Worth, Texas, United States
Children's Hospital and Regional Medical Center - Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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