NCT00042900

Pyroxamide in Treating Patients With Advanced Cancer

A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Precancerous Condition
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pyroxamide

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2003-07-08
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States