Clinical trial · Interventional
Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
A Phase I Pharmacokinetic Study of PS341 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
NCT00054483CI-TRIAL-00010331completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (34)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Grade III Lymphomatoid Granulomatosis | Adult Grade III Lymphomatoid Granulomatosis | ONTOLOGY_EXACT | 0.98 |
| Adult Nasal Type Extranodal NK/T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bortezomib)
- description
- 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.
- interventionNames
- Drug: bortezomib
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Pharmacokinetics in terms of 20S proteasome activity following bortezomib administration
- timeFrame
- Days 1 and 8 pre-infusion (of course 1) and 5, 15, 30, and 60 minutes, and 2, 4, 6, 8, 12, and 24 hours post-bortezomib administration
- measure
- Dose-limiting toxicities of bortezomib graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
- timeFrame
- Up to 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.