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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. ABT-751 in Treating Children With Refractory Solid Tumors

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

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

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