Clinical Trials Directory

Trials / Completed

CompletedNCT00028522

R(+)XK469 in Treating Patients With Advanced Neuroblastoma

Phase I Study Of R(+)XK469 In Patients With Advanced Neuroblastoma

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
85 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
5 Years – 20 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGR(+)XK469Given IV

Timeline

Start date
2001-12-01
Primary completion
2009-09-01
First posted
2003-01-27
Last updated
2013-12-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00028522. Inclusion in this directory is not an endorsement.