Carboplatin and Irinotecan in Treating Children With Refractory 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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.

Detailed Description
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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.

Official Title
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A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors

Conditions
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Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: carboplatin
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
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: carboplatin|nan|
|Drug: irinotecan hydrochloride|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