A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Date de début de l'étude : 1 octobre 2004

Inclusion Criteria: * Histologically confirmed\* solid tumor, including any of the following: * Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET) * Osteosarcoma * Rhabdomyosarcoma * Neuroblastoma * High-grade astrocytoma * Low-grade astrocytoma * Glioblastoma multiforme * Ependymoma * Hepatoblastoma * Germ cell tumors of any site * Rare tumors of interest, including any of the following: * Soft tissue sarcoma * Hepatocellular carcinoma * Childhood/adolescent colorectal carcinoma * Childhood/adolescent renal cell carcinoma * Childhood/adolescent adrenocortical carcinoma * Childhood/adolescent nasopharyngeal carcinoma * Recurrent disease OR refractory to conventional therapy * Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography * Performance status - Karnofsky 50-100% (for patients over age 10) * Performance status - Lansky 50-100% (for patients age 10 and under) * At least 8 weeks * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count ≥ 75,000/mm\^3\* (transfusion independent) * Hemoglobin ≥ 8.0 g/dL\* (RBC transfusions allowed) * Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met * Bilirubin ≤ 3 mg/dL * Creatinine based on age as follows: * ≤ .8 mg/dL (for patients age 5 and under) * ≤ 1.0 mg/dL (for patients age 6 to 10) * ≤ 1.2 mg/dL (for patients age 11 to 15) * ≤1.5 mg/dL (for patients age 16 to 21) * Creatinine clearance or radioisotope glomerular filtration rate \> 20 mL/min * No uncontrolled seizure disorder * No uncontrolled infection * CNS toxicity ≤ grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Recovered from prior immunotherapy * At least 7 days since prior anticancer biologic therapy * More than 1 week since prior growth factors * At least 6 months since prior allogeneic stem cell transplantation * No evidence of active graft-vs-host disease * No concurrent immunomodulating agents * Recovered from prior chemotherapy * No prior oxaliplatin * Prior carboplatin or cisplatin allowed * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * No other concurrent anticancer chemotherapy * Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry * Recovered from prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to ≥ 50% of the pelvis * At least 6 weeks since other prior substantial radiotherapy to the bone marrow * Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated * No other concurrent investigational agents * No other concurrent anticancer agents