NANT2009-03: A Phase I/II Study of MLN8237 in Combination with Irinotecan and Temozolomide for patients with relapsed or refractory Neuroblastoma
What is the purpose of this study?
The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide.
The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan and temozolomide.
Who can participate?
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.
- 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 treatment.
- 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 cefpodoxime.
- 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 else).
- They can't cooperate with the special precautions that are needed for this trial.
Who should I contact for more information?
For more information contact:
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?