Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
Measurable disease (e.g., solid mass with definable dimensions) OR
Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: