Lymphoma Clinical Trial
Official title:
Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies
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.
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