Clinical Trial: PS-341 in Treating Patients With Advanced Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-cell Lymphoproliferative Disorders
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 PS-341 in treating patients who have advanced cancer.
Detailed Summary:
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies.
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
- Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity.
- Regimen B: Once the MTD has been determined in regimen A, patients receive PS-341 IV twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 14 months.
Sponsor: Mayo Clinic
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: October 4, 2000
Date Started: November 1999
Date Completion:
Last Updated: August 1, 2011
Last Verified: August 2011
