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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00233948
First received: October 5, 2005
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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.

Funding Source-FDA OOPD


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 1
Phase 2

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:

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 2013 (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

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
  • There is no limit to prior chemotherapy regimens; in addition, patients 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
Duarte, California, United States, 91010
South Pasadena Cancer Center
Pasadena, California, United States, 91030
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, FDA R01FD003006-03
Study First Received: October 5, 2005
Last Updated: March 5, 2013
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 June 17, 2013