Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma
I. Determine the maximum tolerated dose, recommended phase II dose, and dose-limiting
toxicity of R(+)XK469 in two different dosing schedules in patients with advanced
II. Determine the safety of this drug in these patients. III. Determine the tolerance to
this drug in these patients. IV. Determine the pharmacokinetics and pharmacodynamics of this
drug and its metabolites in these patients.
V. Determine, preliminarily, any antineoplastic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
SCHEDULE A: Patients receive R(+)XK469 intravenously (IV) over 30 minutes on days 1, 3, and
5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of R(+)XK469 until the
recommended phase II dose or maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once
the MTD is determined, additional patients are accrued and treated at the recommended phase
II dose (for a maximum of 20 patients treated at that dose).
SCHEDULE B: Once the recommended phase II dose is determined on schedule A, additional
patients are accrued and receive escalating doses of R(+)XK469 IV over 30-60 minutes on day
1, beginning at a reduced dose. Courses repeat every 3 weeks in the absence of disease
progression or unacceptable toxicity. Dose escalation continues as in Schedule A.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of XK469 in pediatric patients with advanced neuroblastoma
Defined as the highest dose studied for which the incidence of dose-limiting toxicity (DLT) was less than 33%.
Day 29 of course 1
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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