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Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
This study has been completed.
Study NCT00024258   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: July 22, 2009   History of Changes

September 13, 2001
July 22, 2009
March 2001
May 2009   (final data collection date for primary outcome measure)
Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment [ Designated as safety issue: No ]
Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment
Complete list of historical versions of study NCT00024258 on ClinicalTrials.gov Archive Site
Toxicity after every course during treatment [ Designated as safety issue: Yes ]
Toxicity after every course during treatment
 
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood 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:

  • 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.

Phase II
Interventional
Treatment
  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Kidney Cancer
  • Liver Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Retinoblastoma
  • Sarcoma
Drug: arsenic trioxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
 
May 2009   (final data collection date for primary outcome measure)

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
Both
up to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024258
Brian H. Kushner, Memorial Sloan-Kettering Cancer Center
CDR0000068906, MSKCC-01042, CTI-1059, NCI-G01-2014
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian H. Kushner, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP