Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma - Full Text View

Sponsor:	City of Hope Medical Center
Information provided by (Responsible Party):	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00233948

Purpose

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.

Condition	Intervention	Phase
Adult Liposarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma	Drug: nelfinavir mesylate Procedure: biopsy Other: laboratory biomarker analysis Other: pharmacological study Genetic: gene expression analysis Genetic: western blotting Genetic: reverse transcriptase-polymerase chain reaction Other: immunoenzyme technique	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II Study of Nelfinavir in Liposarcoma

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Response rate (Phase II) [ Time Frame: After 3 cycles of treatment ] [ Designated as safety issue: No ]
Time to progression (Phase II) [ Time Frame: 6 months from end of treatment ] [ Designated as safety issue: No ]
DLT and MTD (Phase I) [ Time Frame: 4 weeks from start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration of overall survival (Phase II) [ Time Frame: 6 months from end of treatment ] [ Designated as safety issue: No ]
Duration of progression-free survival (Phase II) [ Time Frame: 6 months from end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	31
Study Start Date:	March 2006
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I 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.	Drug: nelfinavir mesylate Given orally Other Name: Viracept Procedure: biopsy Correlative studies Other Name: biopsies Other: laboratory biomarker analysis Correlative studies Other: pharmacological study Correlative studies Other Name: pharmacological studies Genetic: gene expression analysis Correlative studies Genetic: western blotting Correlative studies Other Names: Blotting, Western Western Blot Genetic: reverse transcriptase-polymerase chain reaction Correlative studies Other Name: RT-PCR Other: immunoenzyme technique Correlative studies Other Name: immunoenzyme techniques

Arms

Assigned Interventions

Experimental: Arm I

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.

Drug: nelfinavir mesylate

Given orally

Other Name: Viracept

Procedure: biopsy

Correlative studies

Other Name: biopsies

Other: laboratory biomarker analysis

Correlative studies

Other: pharmacological study

Correlative studies

Other Name: pharmacological studies

Genetic: gene expression analysis

Correlative studies

Genetic: western blotting

Correlative studies

Other Names:

Blotting, Western
Western Blot

Genetic: reverse transcriptase-polymerase chain reaction

Correlative studies

Other Name: RT-PCR

Other: immunoenzyme technique

Correlative studies

Other Name: immunoenzyme techniques

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, 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion

Patients must have histologically confirmed liposarcoma, which is recurrent, metastatic or unresectable
This is no limit to prior chemotherapy regimens; in addition, they may have prior radiation
All patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (>= 20 mm with conventional techniques or >= 10mm with spiral CT scan); pleural effusions and ascites will not be considered measurable, but may be present in addition to the measurable lesion(s)
ECOG performance status of 0, 1, or 2; patients should have an expected survival of at least 3 months
Absolute neutrophil count >= 1,000/ul
Platelets >= 75000/ul
Total bilirubin =< 2.0 g/dl
AST(SGOT)/ALT(SGPT) =< 2.0X institutional upper limit of normal
Brain metastasis is not an exclusion; however, patients are only eligible if they have had successful control of the brain tumor(s) by surgery or radiation therapy
All prior therapy must have been completed at least 3 weeks prior to the patient's entry on this trial
No concurrent chemotherapy, radiotherapy, immunotherapy or other investigational agents
Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and willingness to sign a written informed consent document

Exclusion

Patient has had prior treatment with or is currently taking a protease inhibitor
Patients enrolled cannot be on the following medications: cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, dihydropyridine calcium antagonists (amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine), sildenafil, dilantin, rifampin or oral contraceptives
Uncontrolled intercurrent illness
Patients must have recovered from any expected toxicities of previous chemotherapy or radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233948

Locations

United States, California
City of Hope Medical Center	Recruiting
Duarte, California, United States, 91010
Contact: Warren Al Chow, MD 800-826-4673 wchow@coh.org
Principal Investigator: Warren Al Chow
City of Hope Medical Group Inc	Recruiting
Pasadena, California, United States, 91105
Contact: Mark Vi McNamara 626-396-2900 mmcnamara@coh.org
Principal Investigator: Mark Vi McNamara

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:

Warren Chow

Beckman Research Institute

More Information

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00233948 History of Changes
Other Study ID Numbers:	04090, NCI-2010-01263, CDR0000438712
Study First Received:	October 5, 2005
Last Updated:	September 19, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Liposarcoma
Sarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012