Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00703664|
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Mantle Cell Lymphoma Recurrent Non-Hodgkin Lymphoma||Drug: Bortezomib Other: Laboratory Biomarker Analysis Drug: Vorinostat||Phase 2|
This was a multicenter, non-randomized phase 2 trial using a Simon two-stage design with 3 cohorts.
I. Estimate the response rates of mantle cell and diffuse large B-cell lymphomas to bortezomib and vorinostat combination therapy.
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.
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 (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas|
|Actual Study Start Date :||July 9, 2008|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 1, 2017|
Experimental: Treatment (vorinostat, bortezomib)
Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically.
Treatment arm consists of 3 cohorts, all receiving the same treatment:
A: Mantle Cell Lymphoma (MCL) - with no prior bortezomib.
B: Mantle Cell Lymphoma (MCL) - with no prior bortezomib.
C: Diffuse Large B-Cell Lymphoma (DLBCL) - with no prior bortezomib.
Bortezomib: 1.3 mg/m^2/d IV days 1, 4, 8, and 11.
Other: Laboratory Biomarker Analysis
Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.
- Overall Response Rate (ORR) [ Time Frame: Up to 9 years ]ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.
- Best Response [ Time Frame: Up to 9 years ]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.
- Progression-free Survival (PFS) [ Time Frame: Up to 9 years ]Median progression-free survival in months per cohort.
- Duration of Partial Response [ Time Frame: Up to 9 years ]Median duration of response per cohort.
- Duration of Stable Disease [ Time Frame: Up to 9 years ]Median duration of stable disease per cohort.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703664
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Montefiore Medical Center-Weiler Hospital|
|Bronx, New York, United States, 10461|
|Montefiore Medical Center - Moses Campus|
|Bronx, New York, United States, 10467|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Beata Holkova||Massey Cancer Center|