Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified childhood solid tumor, protocol specific
Brief 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.
Detailed description
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.
Interventions
DRUGcarboplatin
DRUGirinotecan hydrochloride
Sponsors
National Cancer Institute (NCI)
Bristol-Myers Squibb
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion 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)
Countries
Canada, United States
Outcome results
None listed