Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
OBJECTIVES:
- Determine the response rates of patients with advanced neuroblastoma or other pediatric
solid tumors treated with arsenic trioxide.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with
progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats
every 28 days for a maximum of 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment
1 year
No
Brian H. Kushner, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
01-042
NCT00024258
March 2001
May 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |