Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma
Adult Liposarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma
About this trial
This is an interventional treatment trial for Adult Liposarcoma
Eligibility 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 (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
Sites / Locations
- City of Hope Medical Center
- South Pasadena Cancer Center
Arms of the Study
Arm 1
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.