Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction

Inclusion Criteria:

• Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists

• Tumor types may include any of the following: solid tumors:

  • Non-Hodgkin's lymphoma
  • Hepatocellular carcinoma, as evidenced by liver mass, elevated alpha-fetoprotein level (>= 500 ng/mL), and positive serology for hepatitis
• Pathological confirmation is not required
• Confirmatory evidence for a prior Hepatitis B infection (HBsAg, HBcAb and/or HBsAb) required
• No symptomatic CNS metastases

• Brain metastasis allowed if the following criteria are met:

  • Received prior definitive treatment (radiation and/or surgery
  • Stable disease for >= 4 weeks
  • Not currently on enzyme-inducing anticonvulsants and steroids
• Life expectancy of at least 12 weeks
• Absolute neutrophil count >= 1,000/mm^3
• Platelet count >= 100,000/mm^3
• Biliary obstruction for which a shunt has been placed allowed provided the shunt has been in place for >= 10 days AND liver function is stable, defined as 2 measurements taken >= 2 days apart that qualify the patient for the same hepatic dysfunction stratum
• No biliary sepsis
• Creatinine =< 1.5 mg/dL
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No New York Heart Association class III or IV heart disease
• Not pregnant or nursing
• Negative pregnancy test
• No preexisting neuropathy >= grade 2
• No ongoing or active infection
• No other concurrent uncontrolled illness that would preclude study participation
• No psychiatric illness or social situation that would preclude study compliance
• More than 4 weeks since prior immunotherapy
• More than 4 weeks since prior biologic therapy
• No concurrent prophylactic colony-stimulating factors
• No concurrent immunotherapy
• No concurrent thalidomide
• Concurrent epoetin alfa or darbepoetin alfa for management of cancer-associated anemia allowed
• Recovered from prior chemotherapy (not including liver function)
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No concurrent chemotherapy
• More than 2 weeks since prior radiotherapy
• No prior radiotherapy to > 50% of the bone marrow
• No concurrent radiotherapy
• More than 3 weeks since prior surgery
• No prior bortezomib
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• Concurrent cytochrome P450 interacting agents are allowed provided they are used with caution
• Concurrent bisphosphonate therapy allowed (e.g., pamidronate or zoledronate), except during course 1 of bortezomib administration
• ECOG 0-2
• Fertile patients must use effective contraception during and for 30 days after study participation