Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor
Eligibility 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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
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.