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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: September 13, 2001
Last updated: October 22, 2015
Last verified: October 2015

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 Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Kidney Cancer
Liver Cancer
Ovarian Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment [ Time Frame: 1 year ]

Enrollment: 22
Study Start Date: March 2001
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic Trioxide

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.

Drug: arsenic trioxide

Detailed Description:


  • 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.


Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 40 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


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


  • Creatinine no greater than 2.5 times ULN


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


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


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


  • Not specified


  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00024258

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian H. Kushner, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00024258     History of Changes
Other Study ID Numbers: 01-042
P30CA008748 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2001
Results First Received: October 22, 2015
Last Updated: October 22, 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
metastatic osteosarcoma
recurrent childhood rhabdomyosarcoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
recurrent neuroblastoma
stage III childhood liver cancer
stage IV childhood liver cancer
recurrent childhood liver cancer
childhood hepatoblastoma
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
recurrent Wilms tumor and other childhood kidney tumors
intraocular retinoblastoma
extraocular retinoblastoma
recurrent retinoblastoma
recurrent osteosarcoma
childhood germ cell tumor
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
localized unresectable neuroblastoma
previously untreated childhood rhabdomyosarcoma
childhood desmoplastic small round cell tumor
untreated childhood medulloblastoma
recurrent childhood medulloblastoma
previously treated childhood rhabdomyosarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
childhood teratoma

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Kidney Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Nervous System Diseases
Retinal Neoplasms
Eye Neoplasms
Eye Diseases
Retinal Diseases processed this record on April 28, 2017