Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma (NCT00810576) | Clinical Trial Compass
TerminatedPhase 2
Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
Stopped: Terminated due to slow accrual.
United States1 participantsStarted 2009-01
Plain-language summary
Primary Objectives:
1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.
Secondary Objectives:
1. To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have an established diagnosis of relapsed or refractory T-cell NHL Eligible histologies include; Peripheral T-cell lymphoma (unspecified), CD 30 + anaplastic large cell lymphoma ( ALK-1 positive and ALK-1 negative), angioimmunoblastic T-cell lymphoma, angiocentric/nasal type T/NK-cell lymphoma, intestinal T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, transformed Mycosis fungoides; All patients must have had at last one prior system regimen (radiation therapy does not qualify as systemic treatment).
✓. Patients who are eligible for blood and marrow transplant can receive this treatment to maximal reduction of tumor bulk: A minimum of two cycles of therapy will be given before crossing over to transplant.
✓. Patients must have at least one clear-cut bi-dimensionally measurable site by physical exam and/or computed tomography: Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within four weeks prior to registration of this study.
✓. Patient may have had prior radiation therapy for localized disease: Therapy must be completed at last four weeks before the enrollment in the study.
✓. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
. Patients are required to have adequate bone marrow reserve as indicated: Absolute neutrophil count (ANC) \>/= 1000/mm\^3; Platelets \>/= 80,000/mm\^3; Hemoglobin \>/= 8g/dL; If there is bone marrow involvement by lymphoma then there is no minimum level of counts required; These values must be obtained within two weeks before protocol entry.
✓. Patients must have adequate liver function as indicated by:Bilirubin \</= 1.5 times the upper limit of normal (ULN); Alanine transaminase (ALT) \</= 2 times the (ULN) or aspartate transaminase (AST) \</= 2 times the ULN; These values must be obtained within two weeks before protocol entry.
Exclusion criteria
✕. Patients with: T-cell lymphoma with skin involvement only are excluded if they have no evidence of systemic disease; T-cell prolymphocytic leukemia (T-PLL); T-cell large granular lymphocytic leukemia; Primary cutaneous CD30+ disorders: anaplastic large cell lymphoma and lymphomatoid papulosis
✕. Patients with active Hepatitis B and/or Hepatitis C infection.
✕. Patients with known HIV infection are excluded: These patients are excluded secondary to potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy.
✕. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
✕. Patients with left ventricular ejection fraction (LVEF) \< 45%.
✕. Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: Congestive heart failure; Severe CAD; Cardiomyopathy; Uncontrolled cardiac arrhythmia; Unstable angina pectoris; Recent MI.
✕. Patients with prior exposure to either vorinostat (including other HDAC inhibitors except valproic acid) or bortezomib: Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
✕. Patients who are pregnant or breast-feeding: Effects of this treatment on the fetus and young children are unknown at this time.