Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven't Responded to Therapy
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 recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, recurrent neuroblastoma, recurrent childhood liver cancer, recurrent Wilms tumor and other childhood kidney tumors, childhood central nervous system germ cell tumor, recurrent osteosarcoma, unspecified childhood solid tumor, protocol specific, childhood germ cell tumor, recurrent childhood soft tissue sarcoma, 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, 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, B-cell childhood acute lymphoblastic leukemia, childhood acute basophilic leukemia, childhood acute eosinophilic leukemia, childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, childhood acute promyelocytic leukemia (M3), L1 childhood acute lymphoblastic leukemia, L2 childhood acute lymphoblastic leukemia, L3 childhood acute lymphoblastic leukemia, non-T, non-B, cALLa negative childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, TdT negative childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, childhood chronic myelogenous leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist Curative therapy may include surgery, radiotherapy, chemotherapy, or any combination of these modalities Eligible tumor types include, but are 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 Histologic confirmation may be waived for brain stem or optic glioma Diagnosis of relapsed or refractory leukemia Patients with refractory or second or greater relapsed leukemia must have > 25% blasts in the bone marrow (M3 bone marrow) with or without active extramedullary disease (except for leptomeningeal disease) Relapsed after or failed to respond to frontline curative therapy and no other potentially curative therapy (e.g., radiotherapy, chemotherapy, or any combination of these modalities) exists Patients with acute promyelocytic leukemia must be refractory to treatment with retinoic acid and arsenic trioxide Patients with Philadelphia chromosome positive chronic myelogenous leukemia must be refractory to imatinib No active CNS leukemia (CNS3) PATIENT CHARACTERISTICS: Age: 2 to 18 (solid tumor patients [closed to accrual as of 10/4/2007]) 1 to 21 (leukemia patients) Performance status: For patients age 11 to 21: Karnofsky 50-100% For patients age 1 to 10: Lansky 50-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 (20,000/mm^3 for leukemia patients) Hemoglobin ≥ 8.0 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 times ULN No hepatic dysfunction that would preclude study Renal: Creatinine normal for age OR Creatinine clearance at least 60 mL/min No renal dysfunction that would preclude study Other: No known severe prior hypersensitivity reaction to agents containing Cremophor EL No clinically significant unrelated systemic illness (e.g., serious infections or other organ dysfunction) that would preclude study No grade 2 or greater preexisting sensory neuropathy More than 2 month since prior and no concurrent evidence of graft vs host disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from all therapy-related acute toxic effects (leukemia patients only) Prior epoetin alfa allowed At least 3 days since other prior colony-stimulating factors (e.g., filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-11 (IL-11)) At least 6 months since prior bone marrow transplantation At least 2 months since prior stem cell transplantation or rescue (leukemia patients) At least 7 days since prior therapy with a biological agent and hematopoietic growth factor with the exception of erythropoietin More than 3 weeks since prior monoclonal antibody therapy (leukemia patients only) No concurrent GM-CSF or IL-11 No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from all therapy-related acute toxic effects (leukemia patients only) At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids allowed for the control of symptoms related to tumor-associated edema in patients with brain tumors Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan is performed for the purpose of assessing response to study therapy Must be on a stable or tapering dose of corticosteroids for 7 days prior to study entry (leukemia patients only) Radiotherapy: See Disease Characteristics Recovered from all therapy-related acute toxic effects (leukemia patients only) At least 4 weeks since prior radiotherapy More than 2 weeks since prior local palliative radiotherapy (leukemia patients only) More than 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥50% of the pelvis (leukemia patients only) More than 6 weeks since prior other substantial bone marrow radiotherapy (leukemia patients only) No prior extensive radiotherapy (e.g., craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis) No concurrent anticancer radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior therapy At least 30 days since any prior investigational anticancer therapy At least 1 week since prior known inhibitors of CYP3A4, including any of the following: Antibiotics (i.e., clarithromycin, erythromycin, or troleandomycin) Anti-HIV agents (i.e, delaviridine, nelfinavir, amprenavir, ritonavir, idinavir, saquinavir, or lopinavir) Anti-fungals (i.e., itraconazole, ketoconazole, fluconazole [doses > 3mg/kg/day], or voriconazole) Anti-depressants (i.e., nefaxodone or fluovoxamine) Calcium channel blockers (i.e., verapamil or diltiazem) Anti-emetics (i.e., aprepitant [Emend®]) Miscellaneous agents (i.e., amiodarone) Grapefruit juice No other concurrent investigational agents No concurrent St. John's Wort No concurrent known inhibitors of CYP3A4, including grapefruit juice Concurrent other agents inducing CYP3A4 allowed
Sites / Locations
- Children's National Medical Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office