Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase I/II Study of Nelfinavir in Liposarcoma
RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from
spreading.
PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir
mesylate and to see how well it works in treating patients with recurrent, metastatic, or
unresectable liposarcoma.
OBJECTIVES:
I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.
II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single
agent and to describe the toxicities at each does studied.
III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and
progression free survival in patients with liposarcoma treated with nelfinavir.
V. To evaluate the expression and activity of certain proteins in the tumors of patients
entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1,
p21, NFkB (NFkappaB), caspase 3).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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