Oxaliplatin in Treating Children With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Study of Oxaliplatin in Children With Solid Tumors

Conditions
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Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified childhood solid tumor, protocol specific