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

This study has been suspended.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024258
  Purpose

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
Neuroblastoma
Ovarian Cancer
Retinoblastoma
Sarcoma
Drug: arsenic trioxide
Phase II

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Arsenic    Cancer    Kidney Cancer    Liver Cancer    Neuroblastoma    Ovarian Cancer    Soft Tissue Sarcoma    Wilms' Tumor   

Drug Information available for:   Arsenic trioxide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Toxicity after every course during treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:   120
Study Start Date:   March 2001
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Detailed 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.

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

  Eligibility
Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024258

Locations
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)

Investigators
Study Chair:     Brian H. Kushner, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Brian H. Kushner )
Study ID Numbers:   CDR0000068906, MSKCC-01042, CTI-1059, NCI-G01-2014
First Received:   September 13, 2001
Last Updated:   October 23, 2008
ClinicalTrials.gov Identifier:   NCT00024258
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Retinal Neoplasms
Liver Diseases
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Urogenital Neoplasms
Central Nervous System Neoplasms
Retinoblastoma
Urologic Neoplasms
Osteogenic sarcoma
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Hepatoblastoma
Kidney Diseases
Nervous System Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Eye Neoplasms
Genital Neoplasms, Female
Arsenic trioxide
Endocrine System Diseases
Renal cancer
Testicular Neoplasms
Carcinoma
Neuroectodermal Tumors
Sarcoma
Gastrointestinal Neoplasms
Testicular cancer
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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