Oxaliplatin in Treating Children With Advanced Solid Tumors

St. Jude Children's Research Hospital26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

oxaliplatinDRUG

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Data from ClinicalTrials.gov

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