This phase II trial studies how well bortezomib and vorinostat work in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
This was a multicenter, non-randomized phase 2 trial using a Simon two-stage design with 3 cohorts. PRIMARY OBJECTIVES: I. Estimate the response rates of mantle cell and diffuse large B-cell lymphomas to bortezomib and vorinostat combination therapy. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of the study regimen. II. Observe progression-free survival and response durations. III. Observe the relationship between pretreatment lymphoma cell nuclear v-rel reticuloendotheliosis viral oncogene homolog A (relA) and response. OUTLINE: Patients receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Bortezomib: 1.3 mg/m\^2/d IV days 1, 4, 8, and 11.
Correlative studies
Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Overall Response Rate (ORR)
ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.
Time frame: Up to 9 years
Best Response
Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Time frame: Up to 9 years
Progression-free Survival (PFS)
Median progression-free survival in months per cohort.
Time frame: Up to 9 years
Duration of Partial Response
Median duration of response per cohort.
Time frame: Up to 9 years
Duration of Stable Disease
Median duration of stable disease per cohort.
Time frame: Up to 9 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Weill Medical College of Cornell University
New York, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
...and 2 more locations