Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children
who have advanced neuroblastoma or other 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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