A Phase I Trial of Nelfinavir (Viracept®) in Adults With Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed* solid malignancy for which there is no known curative
therapy

- Relapsed disease OR failed to respond to standard therapy OR refused standard
therapy in cases where no curative option exists NOTE: *An exception to
histological confirmation will be allowed if no tissue is available for review,
the presence of malignancy is documented in a pathology report from an outside
institution, or a new biopsy is contraindicated because of safety.

- Brain metastases allowed provided all of the following criteria are met:

- Prior evaluation and appropriate counseling

- Prior treatment by radiation oncology

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine < 1.5 times ULN

- Not nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- No myocardial infarction within the past 6 months

- No uncontrolled intercurrent illness, including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 28 days since prior chemotherapy or biologic therapy

- No concurrent chemotherapy, biologic therapy, or radiotherapy

- No concurrent hormonal methods of birth control

- No concurrent CYP3A4 inhibitors, including any of the following:

- Antiarrhythmics (e.g., amiodarone, quinidine)

- Neuroleptics (e.g., pimozide)

- Sedative or hypnotic agents (e.g., midazolam hydrochloride, triazolam)

- Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine,
methylergonovine)

- Hydroxymethyl glutaryl co-enzyme A (HMG-CoA) reductase inhibitors (e.g.,
lovastatin, simvastatin, atorvastatin)

- Concurrent pravastatin and rovustatin allowed

- Rifampin

- Rifabutin

- Felodipine

- Nifedipine

- Sildenafil

- Hypericum perforatum (St. John's wort)

- No other concurrent anticancer agents or therapies

- No concurrent escalating doses of corticosteroids for other noncancerous medical
conditions