PS-341 in Treating Patients With Advanced Cancer
- Conditions
- LymphomaLeukemiaMultiple Myeloma and Plasma Cell NeoplasmPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00006362
- Lead Sponsor
- Mayo Clinic
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States