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Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Phase 1/Phase 2
12 Months
30 Years
Open (Enrolling)

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Trial Information

Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Inclusion Criteria

Criteria that need to be met to participate in this study:

- Patients must be > 12 months and < 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. All patients must have at least ONE
site of evaluable disease.

o 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 adequate heart, kidney, liver and bone marrow function. Patients
who have bone marrow disease must still have adequate bone marrow function to enter
the study.

- MLN8237 must be swallowed as whole tablets. Therefore, patients must be able to
swallow pills to be eligible for study. One tablet is the size of small breath mint,
or baby aspirin. Due to the size of MLN8237 tablets, patients must have a body
surface area of at least 0.38 m2 to be eligible for study. A body surface area is a
combination of a patient's height and weight. An example of a child with a BSA of
0.45 is a child that is 25 inches tall and weighs 25 pounds.You can use the link
below to calculate your child's body surface area and determine if they are too small
for this trial.

Patients cannot participate in the study if:

- Patients who have received prior MLN8237 are excluded from all phases of the study.
Patients previously treated with irinotecan and/or temozolomide will be eligible if
they have not had documented progressive disease during treatment with a regimen
containing these agents.

- They have other medical problems that could get much worse if they had this

- They are on dialysis for bad kidney function.

- They are pregnant or breast feeding.

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

- They have an allergy to treatment with cefixime and cefpodixime.

- They have brain metastasis at study entry, or have received cranial spinal radiation.

- They have had an allogeneic stem cell transplant (received stem cell from someone

- They can't cooperate with the special precautions that are needed for this trial.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

To estimate the maximum tolerated dose (MTD), toxicities and pharmacokinetics of MLN8237 when given together with fixed doses of irinotecan and temozolomide in children and young adults with relapsed or refractory neuroblastoma. To determine the response rate for patients with relapsed or refractory neuroblastoma treated with MLN8237, irinotecan, and temozolomide at the identified MTD

Outcome Time Frame:

21 days, from study day 1

Safety Issue:


Principal Investigator

Steven DuBois, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

May 2016

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Texas Children's Cancer Center Houston, Texas  77030-2399
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
University of Chicago Comer Children's Hospital Chicago, Illinois  60637
Childrens Hospital Boston, Dana-Farber Cancer Institute. Boston, Massachusetts  02115
Duke University Medical Center Durham, North Carolina  27710
Children's Healthcare of Atlanta Atlanta, Georgia  30342