Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders

Stopped early · Phase 2

Conditions studied: Lymphoproliferative Disorder

In brief

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.

Key facts

Study ID

NCT00869323

Run by

Masonic Cancer Center, University of Minnesota

People needed

3

Starts

2009-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder
• Has undergone prior solid organ transplant
• Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³
• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
• Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal
• Total bilirubin ≤ 2.0 mg/dL

You may not qualify if…

• Pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Peripheral neuropathy ≥ grade 2
• Known lymphomatous meningitis or central nervous system (CNS) involvement
• HIV infection
• Uncontrolled infection
• Myocardial infarction within the past 6 months or uncontrolled angina
• New York Heart Association class III-IV heart failure
• Severe uncontrolled ventricular arrhythmias
• Evidence of acute ischemia or active conduction system abnormalities by electrocardiogram (EKG)
• Concurrent serious medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
• Diagnosis or treatment for another malignancy within the past 3 years, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
• Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents used in this study
• Less than 14 days since prior investigational drugs
• Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and recovered from toxic effects prior to enrollment

Where it is running

• University of Minnesota Medical Center - Fairview — Minneapolis, Minnesota, United States
• Washington University School of Medicine - Oncology Division — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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