Protocol

ADV921: A Phase II Study of MLN8237 (IND#102984), A Selective Aurora Kinase Inhibitor, In Children with Recurrent/Refractory Solid Tumors and Leukemias (ADVL0921)

Diseases

Solid Tumor : recurrent or refractory solid tumors (including rhabdoid and malignant germ cell tumors of the CNS) and leukemias

Description

This is a phase II study to determine the response rate of MLN8237 drug in children with relapsed (cancer that has come back) or refractory (cancer that continues to grow) cancers. Children and young adults with recurrent or relapsed cancers (solid tumors and leukemias) for which there is no known effective therapy will be eligible. The study drug is taken by mouth once a day for 7 days every 21 days. You can continue to get treatment on this study for up to 2 years, as long as your cancer does not get worse, and you are not having serious side effects from the study drug. After treatment, you will have routine follow-up exams and medical tests. Medical information will be collected for 5 years after entering the study.

Objectives

• To determine the objective response rate to MLN8237 in children with relapsed or refractory solid tumors and leukemias, administered once daily for 7 days every 21 days.
• To learn about side effects of MLN8237 given on this schedule.

Eligibility

• Patient should be greater than 12 months and less than or equal to 21 years of age at enrollment
• Participants with solid tumor limited to the following diagnosis: neuroblastoma – measurable, neuroblastoma – MIBG evaluable, rhabdomyosarcoma, osteosarcoma, Ewing sarcoma/peripheral PNET, non-RMS soft tissue sarcoma, malignant germ cell tumor, Wilms tumor, acute lymphoblastic leukemia, acute myelogenous leukemia, rhabdoid malignancy (CNS too).
• Solid tumor participants must have at least one lesion on MRI or CT that can be measured and the lesion must be at least 20mm in one diameter.
• Participant with leukemia is recurrent or refractory to at least two prior induction or treatment regimens and does not have CNS disease.
• Participant is not currently receiving investigational drug.
• Participant is able to swallow tablets.
• Participant has recovered from all previous therapy and has a performance score of at least 50.

Contact

Cynthia Wetmore, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: 901-595-2544 or 901-595-4599
FAX: 901-595-5353

Or

Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.