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


Phase 1
2 Years
30 Years
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

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


OBJECTIVES:

Primary

- To determine the maximum tolerated dose of vorinostat in combination with iobenguane I
131 in patients with resistant or relapsed neuroblastoma.

- To define the toxicities of vorinostat in combination with therapeutic doses of
iobenguane I 131 in these patients.

Secondary

- To describe, within the context of a phase I study, the response rate in patients
treated with vorinostat and iobenguane I 131.

- To describe histone acetylation levels and norepinephrine transporter mRNA levels in
peripheral blood mononuclear cells after treatment with different doses of vorinostat.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat once daily on days 1-14 and iobenguane I 131 IV over 1½-2
hours on day 3. Patients undergo autologous peripheral blood stem cell transplantation on
day 17.

Blood samples may be collected periodically for correlative biological studies.

After completion of study treatment, patients are followed up periodically.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All toxicities , including dose limiting toxicities, of the combination of vorinostat with therapeutic doses of 131-I MIBG

Outcome Description:

All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE) and attribution. Tables will be created to summarize these toxicities and side effects by dose level and by course.

Outcome Time Frame:

From day 1 of vorinostat therapy to 56 days after stem cell re-infusion

Safety Issue:

Yes

Principal Investigator

Steven DuBois, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSF Medical Center at Parnassus

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000659059

NCT ID:

NCT01019850

Start Date:

March 2010

Completion Date:

May 2014

Related Keywords:

  • Neuroblastoma
  • disseminated neuroblastoma
  • localized unresectable neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital BostonBoston, Massachusetts  02115
Duke University Medical CenterDurham, North Carolina  27710
Children's Healthcare of AtlantaAtlanta, Georgia  30342
C.S Mott Children's HospitalAnn Arbor, Michigan  48109
Lucile Salter Packer Children's HospitalPalo Alto, California  94304
University of Chicago, Comer Children's HospitalChicago, Illinois  60637