Recurrent Neuroblastoma Clinical Trial
Official title:
Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma
This phase I trial is studying the side effects and best dose of R(+)XK469 in treating patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
OBJECTIVES:
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
neuroblastoma.
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
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