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Lead
National Cancer Institute (NCI)
OBJECTIVES:
I. Estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors.
II. Assess the toxicity of gemcitabine in this patient population. III. Determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents.
IV. Assess the antitumor activity of gemcitabine within a phase I study.
OUTLINE: This is a dose escalation study.
Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at week 4 and then every 6 months until death.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor Confirmation made at original diagnosis
No bone marrow involvement
Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List
PATIENT CHARACTERISTICS:
Age: 1 to 21
Performance status: 0-2
Life expectancy: At least 2 months
Absolute neutrophil count at least 1,000/mm3
Platelet count at least 100,000/mm3 (transfusion independent)
Hemoglobin at least 10 g/dL (transfusions allowed)
Bilirubin no greater than 1.5 times normal
AST less than 2.5 times normal
Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min
No seizure disorder Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior cytokine therapy and recovered
No prior bone marrow transplantation
No more than 3 prior combination or single agent chemotherapy regimens
At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
Clareo Health | Gemcitabine in Treating Children With Refractory Solid Tumors
