Status:
TERMINATED
Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Lymphoproliferative Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab. Secon...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00869323
Start Date
March 1 2009
End Date
December 1 2016
Last Update
December 5 2017
Active Locations (2)
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1
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States, 55455
2
Washington University School of Medicine - Oncology Division
St Louis, Missouri, United States, 63110