RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with bortezomib in treating patients with relapsed or progressive advanced hematologic cancer.
OBJECTIVES: * To assess the safety of nelfinavir mesylate in combination with bortezomib in patients with relapsed or progressive, advanced hematologic malignancies. * To establish the phase II recommended dose of nelfinavir mesylate in these patients. OUTLINE: This is a multicenter, dose-escalation study of nelfinavir mesylate. Patients receive oral nelfinavir mesylate twice daily on days 1-21 and bortezomib IV on days 8, 11, 15, and 18 in course 1. Course 1 has a duration of 28 days. Beginning in course 2, patients receive oral nelfinavir mesylate twice daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for 2 courses. Patients with responding disease may continue to receive nelfinavir mesylate and bortezomib for up to 4 additional courses. After completion of study treatment, patients are followed for 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Bortezomib i.v., day 8, 11, 15, 18; 1.3 mg/m2
p.o., days 1 to 21; dose level: (625), 1250, 1875, or 2500 mg, 2x/d
Inselspital Bern
Bern, Switzerland
Kantonsspital Graubuenden
Chur, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
Dose limiting toxicity
Time frame: during first cycle
Objective response
Time frame: during treatment
Adverse events according to NCI CTCAE v.4.0
Time frame: during treatment + 30 days
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