Clinical Trial: Pyroxamide in Treating Patients With Advanced Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.
Detailed Summary:
OBJECTIVES:
- Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
- Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
- Describe the pharmacologic behavior of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: August 5, 2002
Date Started: April 2002
Date Completion:
Last Updated: June 4, 2013
Last Verified: June 2013
