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.

Condition	Treatment or Intervention	Phase
childhood cancer	Drug: arsenic trioxide  Procedure: chemotherapy	Phase II

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.

PROJECTED ACCRUAL: A total of 45-120 patients (15-40 per stratum) will be accrued for this study.

Ages Eligible for Study:  up to  40 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
• Ewing's family of tumors/primitive neuroectodermal tumor
• Retinoblastoma
• Nephroblastoma
• Osteosarcoma
• Rhabdomyosarcoma
• Desmoplastic small round-cell tumor
• Hepatoblastoma
• Germ cell tumors
• Medulloblastoma
• 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:

• 40 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 2.5 times ULN

Cardiovascular:

• Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels

Other:

• No pre-existing neurotoxicity/neuropathy grade 2 or greater
• No pre-existing convulsive disorder
• No active serious infections uncontrolled by antibiotics
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• More than 3 weeks since prior cytotoxic chemotherapy
• No other concurrent cytotoxic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field

Surgery:

• Not specified

Other:

• No other concurrent investigational agents

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Brian H. Kushner, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000068906; MSKCC-01042; CTI-1059; NCI-G01-2014
Record last reviewed:  May 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024258
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29