Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas. II. Determine the toxic effects and pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of flavopiridol 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 every 6 months. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Given IV
Correlative studies
COG Phase I Consortium
Arcadia, California, United States
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
Time frame: Day 21
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