Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

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