Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	40 and under	NCI, Pharmaceutical / Industry	MSKCC-01042 CTI-1059, NCI-G01-2014, NCT00024258

Objectives

1. Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
2. Determine the toxicity of this drug in these patients.

Entry 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)

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

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

Expected Enrollment

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

Outcomes

Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment

Toxicity after every course during treatment

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Brian Kushner, MD, Protocol chair		Ph: 212-639-6793; 800-525-2225 Email: kushnerb@mskcc.org

Registry Information
Official Title		Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
Trial Start Date		2001-03-27
Trial Completion Date		2009-05-26
Registered in ClinicalTrials.gov		NCT00024258
Date Submitted to PDQ		2001-07-17
Information Last Verified		2009-07-21
NCI Grant/Contract Number		CA08748

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