Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Condition: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma
MeSH terms: Neoplasms; Sarcoma; Liver Neoplasms; Neuroblastoma; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Retinoblastoma
Intervention: arsenic trioxide
Intervention MeSH terms: Arsenic Trioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Maximum age: 40 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

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