TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for
neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a
currently approved drug). An investigational drug is one that has not yet been approved by
the Food and Drug Administration. This investigational drug is called TPI 287. This study
will look at the safety and tolerability of TPI 287 both alone and in combination with
temozolomide, and look to establish a safe dose of this agent. The study will also look at
the tumor's response to these drugs, but this is not the primary objective of this study.
TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in
three different animal species. TPI 287 has been tested in humans in four clinical trials,
and approximately 100 subjects with various types of cancers have received the drug. All of
these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a
pediatric population before this study.
Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently
published study. Preclinical studies of TPI in combination with temozolomide have shown at
minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in
combination is suggested by these two drugs showing even greater activity when used together.