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Research and Clinical Trials

Brief Description  
Despite the advances made in childhood cancer survivorship in recent years, overall survival for those patients who experience relapse or are refractory to treatment remains poor. For many heavily pre-treated patients, there are few therapeutic options. This is a Phase II single-arm study of a single agent, MLN8237 to evaluate efficacy in pediatric patients with relapsed or refractory solid malignancies or acute leukemias (ALL and AML). As a small molecule inhibitor of aurora A kinase, MLN8237 h
Who may be Eligible  

Patients must be >12 months and < 22 years of age at the time of study enrollment.

Patients must have had histologic verification of malignancy at original diagnosis or at relapse, to include any of the following malignancies (no other histology is eligible):
  1. Neuroblastoma- measurable
  2. Neuroblastoma- MIBG evaluable
  3. Rhabdomyosarcoma
  4. Osteosarcoma
  5. Ewing sarcoma/Peripheral PNET
  6. Non-RMS soft tissue sarcoma
  7. Hepatoblastoma
  8. Malignant germ cell tumor
  9. Wilms tumor
  10. Acute lymphoblastic leukemia
  11. Acute myelogenous leukemia
Patients with solid tumors must have radiographically measurable disease (with the exception of neuroblastoma, which may be MIBG + without measurable disease)

Patients with leukemia must be recurrent or refractory to at least two prior induction or treatment regimens (ALL patients must have >25% blasts in the bone marrow and AML patients must have >5% blasts). Patients with CNS leukemia are not eligible.

Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment

Patients must have adequate bone marrow, renal, and liver function.

Patients who are unable to swallow pills are NOT eligible.
Speciality/Disorder  
Pediatric Cancer
IRB Number  
04-11-03A
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Julie  A, Chasnis
Phone:  (704) 446-5154  Fax:  (704) 355-1188  
Email:  julie.chasnis@carolinashealthcare.org
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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