Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Completed · Phase 1
Conditions studied: Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Multiple Myeloma, Splenic Marginal Zone Lymphoma, Stage III Multiple Myeloma, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Immunoblastic Large Cell Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific, Waldenström Macroglobulinemia
In brief
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.
Key facts
- Study ID
- NCT00054483
- Run by
- National Cancer Institute (NCI)
- People needed
- 69
- Starts
- 2003-01-01
- Last updated by the study team
- 2013-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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