ABT-751 in Treating Young Patients With Refractory 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, childhood infratentorial ependymoma, recurrent childhood rhabdomyosarcoma, childhood supratentorial ependymoma, childhood craniopharyngioma, disseminated neuroblastoma, recurrent neuroblastoma, recurrent childhood liver cancer, stage IV childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, stage IV Wilms tumor, childhood central nervous system germ cell tumor, recurrent osteosarcoma, unspecified childhood solid tumor, protocol specific, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma, 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 solid tumor*, including, but not limited to, the following: Rhabdomyosarcoma Other soft tissue sarcomas Ewing's sarcoma family of tumors Osteosarcoma Neuroblastoma Wilms' tumor Hepatic tumors Germ cell tumors Primary brain tumors Brain stem or optic gliomas (histological confirmation may be waived if a biopsy has not been performed) NOTE: *Closed to accrual for all diagnoses except neuroblastoma as of 4/16/05 Relapsed after or failed to respond to frontline standard therapy and no other standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any combination of these modalities) exist Measurable or evaluable disease* NOTE: *Not required for patients with neuroblastoma No CNS tumor with motor or sensory deficits that would obscure the study assessment of sensory neuropathy PATIENT CHARACTERISTICS: Age: 18 and under Performance status: Lansky 60-100% (age 10 and under) Karnofsky 60-100% (age 11 to 18) Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the maximum tolerated dose is determined) No clinically significant hepatic dysfunction Renal: Creatinine normal for age OR Creatinine clearance at least 60 mL/min No clinically significant renal dysfunction Cardiovascular: LVEF normal by echocardiogram Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No allergy to sulfa-containing medications No clinically significant unrelated systemic illness (e.g., other organ dysfunction) that would preclude study participation No serious infection No preexisting grade 2 or greater sensory or motor neuropathy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 months since prior bone marrow transplantation At least 72 hours since prior interleukin-11 At least 72 hours since prior colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) except epoetin alfa No concurrent growth factors (e.g., GM-CSF) except epoetin alfa Concurrent G-CSF allowed if neutropenia lasts longer than 5 days OR if the patient experiences confirmed septicemia associated with neutropenia No concurrent immunotherapy No concurrent interleukin-11 Chemotherapy: See Disease Characteristics At least 30 days since prior chemotherapy (42 days for nitrosoureas) No other concurrent anticancer chemotherapy Endocrine therapy: Patients with brain tumors: Must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan performed for the purpose of assessing response to study therapy Concurrent corticosteroids allowed for control of symptoms of tumor-associated edema Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy At least 4 months since prior extensive radiotherapy (craniospinal radiotherapy, total body irradiation, or radiotherapy to more than 50% of the pelvis) No concurrent radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior therapy At least 30 days since prior investigational anticancer therapy No other concurrent investigational agents
Sites / Locations
- Children's Memorial Hospital - Chicago
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- Children's Hospital of Philadelphia