Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma
Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor
About this trial
This is an interventional treatment trial for Childhood Burkitt Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy at either original diagnosis or relapse, including the following: Solid tumor, including primary CNS tumors Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week Patients with CNS tumors must be on stable or decreasing doses of dexamethasone for the past 7 days Histology requirement waived for intrinsic brain stem tumors Lymphoma Measurable or evaluable disease No known curative therapy or no therapy proven to prolong survival with an acceptable quality of life exists Patients with known bone marrow metastases are eligible for study but are not evaluable for hematologic toxicity Not known to be refractory to red blood cell or platelet transfusions Karnofsky performance score (PS) 60-100% (> 10 years of age) or Lansky PS 60-100% (≤ 10 years of age) Absolute neutrophil count ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study enrollment) Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed) Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows: No greater than 0.8 mg/dL (≤ 5 years of age) No greater than 1.0 mg/dL (6 to 10 years of age) No greater than 1.2 mg/dL (11 to 15 years of age) No greater than 1.5 mg/dL (> 15 years of age) Bilirubin ≤ 1.5 times upper limit of normal ALT ≤ 45 U/L Albumin ≥ 2 g/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of active graft-vs-host disease No uncontrolled infection Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) More than 1 week since prior growth factors, including those that support platelet or WBC number or function At least 1 week since prior biologic agents At least 2 weeks since prior local, palliative, small-port external-beam radiotherapy At least 6 months since prior total body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50%of the pelvis At least 6 weeks since other prior substantial bone marrow radiotherapy (i.e., skull, spine, pelvis, or ribs) At least 3 months since prior stem cell transplantation or rescue without TBI No other concurrent investigational drugs No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy No concurrent enzyme-inducing anticonvulsants, including any of the following: Phenytoin Phenobarbital Felbamate Primdone Oxcarbazepine Carbamazepine No concurrent agents that inhibit CYP3A4, including any of the following: Itraconazole Ketoconazole Voriconazole
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive ispinesib IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.