NCT00233948

Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma

A Phase I/II Study of Nelfinavir in Liposarcoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Liposarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	nelfinavir mesylate	Given orally
PROCEDURE	biopsy	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
GENETIC	gene expression analysis	Correlative studies
GENETIC	western blotting	Correlative studies
GENETIC	reverse transcriptase-polymerase chain reaction	Correlative studies
OTHER	immunoenzyme technique	Correlative studies

Timeline

• Start date: 2006-03-01
• Primary completion: 2013-07-01
• First posted: 2005-10-06
• Last updated: 2015-04-01
• Results posted: 2015-02-23

Locations

2 sites across 1 country: United States