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



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

For Condition: childhood cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /40 Years
Genders: Both
Protocol 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) 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BrianKushner,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Brian  Kushner 212-639-6793


Additional Information:
Study ID Numbers:  CDR0000068906;  CTI-1059,MSKCC-01042,NCI-G01-2014
Study Start Date: 
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024258

Other Childhood Cancer Studies:
1. Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

2. Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors

3. ABT-751 in Treating Children With Refractory Solid Tumors

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