A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
OBJECTIVES:
I. Determine the safety and toxicity of bortezomib and fludarabine with or without rituximab
in patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic
lymphocytic leukemia.
II. Determine the maximum tolerated dose of bortezomib in combination with fludarabine in
these patients.
III. Determine the biological effect of this regimen on apoptotic markers, cell cycle kinase
inhibitors, and DNA repair in these patients.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV
over 30 minutes on days 1-3 or 1-5. Patients may also receive rituximab IV over 1 hour on
day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria version 2.0
3 weeks
Yes
Brenda Cooper
Principal Investigator
Case Western Reserve University
United States: Food and Drug Administration
NCI-2009-00044
NCT00068315
July 2003
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Mercy Medical Center | Springfield, Ohio 45504 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Southwest General Health Center Ireland Cancer Center | Middleburg Heights, Ohio 44130 |
UHHS-Chagrin Highlands Medical Center | Orange Village, Ohio 44122 |
UHHS-Westlake Medical Center | Westlake, Ohio 44145 |
University Suburban Medical Center | South Euclid, Ohio 44121 |