A Phase I/II Study of Nelfinavir in Liposarcoma

Inclusion 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