PS-341 in Treating Patients With Metastatic Malignant Melanoma

Inclusion Criteria:

Histologically or cytologically confirmed metastatic malignant melanoma
Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm
Absolute neutrophil count (ANC) >= 1500/uL
PLT >= 100,000/uL
Total bilirubin =< 2.5 x institutional upper normal limit (UNL)
AST =< 2.5 x UNL
Creatinine =< 1.5 x UNL or calculated creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x UNL using the Cockcroft-Gault formula
Life expectancy of >= 3 months
ECOG performance status 0 or 1
Capable of understanding the investigational nature, potential risks and benefits of the study and willing to sign the written informed consent document

Exclusion Criteria:

Any of the following:

Any prior chemotherapy
Immunotherapy =< 4 weeks prior to study entry
Biologic therapy =< 4 weeks prior to study entry
Radiation therapy =< 4 weeks prior to study entry
Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
Known brain metastases requiring active treatment; NOTE: these patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS-341

Uncontrolled intercurrent illness including, but not limited to:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris, cardiac arrhythmia
Psychiatric illness that would limit compliance with study requirements
HIV-positive patients receiving combination anti-retroviral therapy; NOTE: patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with PS-341; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

Any of the following:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, subcutaneous implants, intrauterine device [IUD], abstinence, etc.)
NOTE: this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown

Only non-measurable disease, including lesions not clearly measurable in one dimension, small lesions (longest diameter < 20 mm), and truly non-measurable lesions, which include the following as per RECIST criteria:

Bone lesions
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Inflammatory breast disease
Lymphangitis cutis/pulmonis
Abdominal masses that are not confirmed and followed by imaging techniques
Cystic lesions