Trial Search Results

Study of MLN8237 in Combination With Irinotecan and Temozolomide

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 (alisertib) 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

New Approaches to Neuroblastoma Therapy Consortium

Stanford Investigator(s):

Intervention(s):

  • Drug: MLN8237
  • Drug: Irinotecan
  • Drug: Temozolomide

Phase:

Phase 1/Phase 2

Eligibility


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 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 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
   else).

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

Ages Eligible for Study

12 Months - 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
Pediatric Hematology/Oncology
650-723-5535
Not Recruiting