Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
About this trial
This is an interventional basic science trial for Adult Grade III Lymphomatoid Granulomatosis
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Experimental
Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.