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

This study has been terminated.
(Drug availability issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233948
First Posted: October 6, 2005
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
City of Hope Medical Center
October 5, 2005
October 6, 2005
February 2, 2015
February 23, 2015
April 1, 2015
March 2006
July 2013   (Final data collection date for primary outcome measure)
  • Dose Limiting Toxicity (DLT) (Phase I) [ Time Frame: 4 weeks from start of treatment, up to 2 years ]
    DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid
  • Maximum Tolerated Dose (MTD) (Phase I) [ Time Frame: 4 weeks from start of treatment, up to 2 years ]
    The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.
  • Overall Response Rate (Phase II) [ Time Frame: After 3 cycles of treatment, up to 2 years. ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Not Provided
Complete list of historical versions of study NCT00233948 on ClinicalTrials.gov Archive Site
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Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adult Liposarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • 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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
Not Provided
July 2013   (Final data collection date for primary outcome measure)

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 (Eastern Cooperative Oncology Group) 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00233948
04090
NCI-2010-01263
CDR0000438712 ( Registry Identifier: PDQ )
FDA R01FD003006-03 ( Other Identifier: FDA Office of Orphan Products Development )
Yes
Not Provided
Not Provided
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Warren Chow City of Hope Medical Center
City of Hope Medical Center
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP