Clinical Trial: XK469R in Treating Patients With Refractory Hematologic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Study of XK469R (NSC 698215) in Patients With Refractory Hematologic Malignancies

Brief Summary: Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer. Drugs used in chemotherapy, such XK469R, work in different ways to stop cancer cells from dividing so they stop growing or die

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of XK469R in patients with refractory hematologic malignancies.

II. Determine the pharmacokinetics of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the presence of genetic variations potentially affecting XK469R disposition in patients treated with this drug.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive XK469R IV over 30-60 minutes on days 1, 3, and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of XK469R until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • MTD as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 21 days ]
  • Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications using CTCAE version 3.0 [ Time Frame: 21 days ]


Original Primary Outcome:

Current Secondary Outcome:

  • Pharmacokinetic profile of XK496R [ Time Frame: At baseline, at 15 and 30 minutes, and at 1, 2, 4, 6, 8, and 24 hours (of days 1-2), and at days 3 and 5 ]
  • Candidate genes for XK469R using PCR assay [ Time Frame: At baseline ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2004
Date Started: October 2004
Date Completion:
Last Updated: February 7, 2013
Last Verified: February 2013