Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction

Inclusion Criteria:

• Histologic proof of malignancy (including non-Hodgkin's lymphoma and multiple myeloma)
• Patients must have measurable or evaluable disease; patients with reliable tumor markers (as determined by protocol chairman) are eligible for participation
• ANC >= 1000/uL
• PLT >= 50,000/uL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• AST =< 2.5 x ULN or AST =< 5 x ULN if liver involvement
• Patients with abnormal kidney function will be allowed and will be grouped accordingly
• Willingness to return to treating institution for follow-up
• Life expectancy >= 12 weeks
• Willingness to provide all biologic specimens as required by the protocol

Exclusion Criteria:

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• ECOG performance status (PS) 3 or 4
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Any of the following prior therapies:

  • Chemotherapy ≤ 4 weeks
  • Mitomycin C/nitrosoureas ≤ 6 weeks
  • Immunotherapy ≤ 4 weeks
  • Biologic therapy ≤ 4 weeks
  • Radiation therapy ≤ 2 weeks
  • Radiation to > 50 % of bone marrow (excepting patients who have had total body irradiation incorporated into bone marrow or stem cell transplantation; all other eligibility criteria still apply)
  • PS-341 treatment
• Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment (excludes renal function)
• New York Heart Association classification III or IV
• Symptomatic CNS metastases; patients who have received definitive treatment for brain metastases (radiation and/or surgery) and are stable for >= 8 weeks are eligible; eligible patients with brain metastases should not be taking enzyme-inducing anticonvulsants and should be receiving stable doses of steroids

• 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, intrauterine device [IUD], or abstinence, etc.)
  • This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
• Other concurrent chemotherapy, immunotherapy, or radiotherapy
• HIV-positive patients receiving anti-retroviral therapy (HAART); there is a potential for pharmacokinetic interactions
• Concurrent use of other investigational agent (including thalidomide); bisphosphonate therapy (e.g. pamidronate or zoledronate) will not be considered investigational agents for the purpose of trial eligibility
• Pre-existing grade >= 2 neuropathy