Leigh Marcus, M.D., National Cancer Institute
Special Project funded 2010-2011
We would like to thank the CBTF for supporting our phase 1 clinical trial of Satraplatin in children with brain tumors. Although overall survival for children with CNS tumors is rising, new agents that are more effective and less toxic are desperately needed. Chemotherapeutic agents including platinum (e.g. cisplatin, carboplatin) have been studied in children with brain tumors such as low and high grade astrocytomas, medulloblastomas, and brain stem gliomas, ad are frequently utilized in standard chemotherapy regimens. However, platinum agents are associated with significant toxicities, such as renal toxicity, neurotoxicity, decreased hearing, and bone marrow suppression. Satraplatin is a new platinum agent that is administered orally and has been associated with fewer side effects in initial studies. It also crosses the blood:brain barrier with levels that are expected to be adequate for antitumor activity. Satraplatin has demonstrated some activity in adults with solid tumors. However it has never been evaluated in children.
Our Phase I study of Satraplatin in children will be open for children 3-21 years old, with solid tumors including brain tumors that are refractory to standard treatment. Satraplatin will be given once daily for 5 days and repeated every 28 days. Because this is the initial study done in children, we will study the pharmacokinetics of this agent, evaluating how satraplatin is handled (absorbed, metabolized, eliminated) by the body. Funding from the CBTF grant will be used to study the drug’s shelf life, which in the past had been done in a special laboratory. We hope to continue on to a phase 2 clinical trial at successful completion of the phase 1.