carboplatin and irinotecan in treating children with refractory 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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.

objectives: * determine the maximum tolerated dose and recommended phase ii dose of carboplatin and irinotecan in children with refractory solid tumors. * determine the safety profile and dose-limiting toxic effects of this regimen in these patients. * determine the pharmacokinetics of this regimen in these patients. * determine the preliminary anti-tumor activity of this regimen in these patients. outline: this is a dose-escalation study of carboplatin and irinotecan. patients receive carboplatin iv over 50 minutes on day 1 and irinotecan iv over 1 hour on days 1-5 and 8-12. treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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. patients are followed for at least 30 days. projected accrual: a total of 25-30 patients will be accrued for this study within 6-9 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed solid tumor, including primary brain tumor * progressive disease on standard therapy or for which no standard therapy exists * no symptomatic brain metastases patient characteristics: age: * 1 to 21 performance status: * lansky 50-100% (age 10 and under) * karnofsky 50-100% (over age 10) life expectancy: * at least 8 weeks hematopoietic: * absolute neutrophil count greater than 1,000/mm3 * platelet count greater than 100,000/mm3 hepatic: * bilirubin no greater than 1.5 mg/dl * alt no greater than 2.5 times upper limit of normal renal: * glomerular filtration rate at least 30 ml/min other: * no active infection * no serious uncontrolled medical disorder * no psychiatric disorder or other disorder that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease * at least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunotherapy chemotherapy: * no more than 3 prior chemotherapy regimens * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * no other concurrent chemotherapy endocrine therapy: * concurrent hormone replacement therapy or oral contraceptives allowed * no other concurrent hormonal therapy radiotherapy: * at least 4 weeks since prior radiotherapy (including for brain metastases) and recovered * no concurrent radiotherapy surgery: * not specified other: * no other concurrent investigational anticancer drugs * no other concurrent antitumor therapy * no concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (neurontin)

Keywords: unspecified childhood solid tumor, protocol specific