NCT01483820

Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma

A Phase I/II Trial of TPI-287 in Patients With Refractory or Recurrent Neuroblastoma and Medulloblastoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Giselle Sholler · Academic / Other
• Sex: All
• Age: 12 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma. 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 tumor's response to the study drug, TPI 287, as well as the safety and tolerability of the drug. 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, including a pediatric population in our previous Phase I trial.

Conditions

• Neuroblastoma
• Medulloblastoma

Interventions

Type	Name	Description
DRUG	TPI 287	Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-01
• Last updated: 2024-08-06
• Results posted: 2016-10-28

Locations

8 sites across 1 country: United States