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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Treatments: Nelfinavir

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