Spots Global Cancer Trial Database for PS-341 in Treating Patients With Advanced Cancer

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Trial Identification

Brief Title: PS-341 in Treating Patients With Advanced Cancer

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

Study ID: NCT00006362

Conditions

Leukemia

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Precancerous Condition

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

bortezomib

Study Description

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.