A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-cell Lymphoproliferative Disorders
- Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these
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.
Primary Purpose: Treatment
Alex A. Adjei, MD, PhD
United States: Federal Government
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|