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Brief Title: Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma
Official Title: A Phase I/II Trial of TPI-287 in Patients With Refractory or Recurrent Neuroblastoma and Medulloblastoma
Study ID: NCT01483820
Brief 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.
Detailed Description:
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Rady Children's Hospital, San Diego, California, United States
Connecticut Children's Hospital, Hartford, Connecticut, United States
Arnold Palmer Hospital for Children- MD Anderson, Orlando, Florida, United States
Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Name: Nehal Parikh, MD
Affiliation: Connecticut Children's Hospital
Role: STUDY_CHAIR
Name: Giselle Sholler, MD
Affiliation: Beat Childhood Cancer at Atrium Health
Role: PRINCIPAL_INVESTIGATOR