Clinical Trials Directory

Trials / Terminated

TerminatedNCT00004239

506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment

A Phase I Study of Compound 506U78 (NSC #686673) in Patients With Hematologic Malignancies and Renal or Hepatic Impairment

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients. OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGCompound 506U78

Timeline

Start date
1999-12-01
Primary completion
2002-01-01
Completion
2002-01-01
First posted
2004-01-29
Last updated
2016-07-04

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00004239. Inclusion in this directory is not an endorsement.