oxaliplatin in treating children with advanced solid tumors

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.

objectives: * determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors. * determine the toxic effects of this drug in these patients. * determine the safety of this drug in these patients. * determine the pharmacokinetics of this drug in these patients. * assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients. * determine the anti-tumor effects of this drug in these patients. outline: this is a dose-escalation study. patients receive oxaliplatin iv over 2 hours on day 1 (every 3 weeks for up to 6 courses) or on days 1, 14, and 28 (every 6 weeks for up to 3 courses). treatment continues in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses). projected accrual: approximately 6-20 patients will be accrued for this study within 1-3.3 years.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment * histological confirmation not required for brain stem tumors * no known brain metastases * no leukemia patient characteristics: age: * 21 and under performance status: * ecog 0-2 or * lansky 50-100% life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,000/mm\^3 (except with marrow involvement) * hemoglobin at least 8 g/dl * platelet count at least 100,000/mm\^3 hepatic: * bilirubin 0.2-1.4 mg/dl * ast/alt no greater than 3 times upper limit of normal renal: * creatinine normal for age or * creatinine clearance at least 50 ml/min * electrolytes, calcium, and phosphorus normal cardiovascular: * no symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia other: * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no active graft-vs-host disease (gvhd) * no allergy to platinum compounds or antiemetics * no uncontrolled concurrent illness or infection * no evidence of neuropathy * blood sugar normal prior concurrent therapy: biologic therapy: * at least 1 week since prior hematopoietic growth factors * at least 3 months since prior stem cell transplantation and recovered chemotherapy: * at least 3 weeks since prior chemotherapy (6 weeks for nitrosourea) endocrine therapy: * not specified radiotherapy: * at least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment * at least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and y-port radiotherapy * at least 6 months since prior total body irradiation surgery: * not specified other: * no concurrent therapy for gvhd * no other concurrent anticancer investigational or commercial agents * no other concurrent anticancer therapy

Keywords: unspecified childhood solid tumor, protocol specific