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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Sarcoma; Neuroblastoma; Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Kidney Cancer; Childhood Germ Cell Tumor; Ovarian Cancer; Liver Cancer; Retinoblastoma

Treatments: Drug: arsenic trioxide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00024258

P30CA008748 (U.S. NIH Grant/Contract)

01-042

NCI-G01-2014

MSKCC-01042

CTI-1059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: Under 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Arsenic Trioxide

Experimental group

Description:

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.

Treatment:

Drug: arsenic trioxide