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Status:

COMPLETED

Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Mantle Cell Lymphoma

Recurrent Non-Hodgkin Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 an...

Detailed Description

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 lymphom...

Eligibility Criteria

Inclusion

  • Histologically confirmed mantle cell or diffuse large B-cell lymphoma; histological material must be available for central pathological review; unstained histological material -- slides or blocks -- must be available for correlative studies; archived material from previous biopsies is acceptable, unless a patient's lymphoma has been known to undergo histological transformation in the past, in which case a repeat biopsy to confirm histology prior to enrollment is required; availability of material must be confirmed at the time of registration, but material may be submitted subsequent to registration and initiation of study treatment
  • Measurable disease according to the Revised Response Criteria for Malignant Lymphoma; this requires at least one lesion greater than 1.0 cm in diameter in both the long and short axis as measured by spiral computed tomography (CT) scan or physical exam
  • Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
  • \>= 6 months have elapsed since allogeneic transplant
  • No graft vs. host disease (GVHD) is present
  • Not currently on immunosuppressive therapy
  • Prior therapy:
  • Mantle cell lymphoma:
  • Previously treated or untreated
  • No prior bortezomib
  • Diffuse large B-cell lymphoma:
  • At least one prior systemic therapy
  • No prior bortezomib
  • Note: Not intended for patients in first relapse who are candidates for high dose therapy with stem cell support
  • Life expectancy of greater than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Able to tolerate loperamide or other anti-diarrheal medications
  • Absolute neutrophil count \>= 1.5 x 10\^9/L
  • Platelets \>= 75 x 10\^9/L
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transferase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits or calculated creatinine clearance \>= 60 mL/min according to the Cockcroft-Gault formula
  • For patients with known human immunodeficiency virus (HIV) infection, a cluster of differentiation (CD)4 count \>= 0.5 x 10\^9/L
  • For patients whose last treatment included bendamustine or fludarabine, a CD4 count \>= 0.4 x 10\^9/L
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and to report pregnancy or suspected pregnancy while participating in the study
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion

  • Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study
  • Prior histone deacetylase inhibitor as cancer treatment
  • Concurrent treatment with other investigational agents
  • Plans for other concurrent cancer treatment; if steroids for cancer control have been used, patients must be off these agents for \>= 1 week before starting treatment; exception: maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose \< 10 mg/day is permitted
  • History of brain metastasis including leptomeningeal metastasis
  • Grade \>= 2 neuropathy, regardless of cause
  • Unable to take oral medications
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or vorinostat
  • Not sufficiently recovered from previous treatment
  • Medical or other condition (for example: uncontrolled infection; potentially life threatening changes on electrocardiogram \[EKG\]) or concurrent treatment (for example, marrow suppressive agents such as zidovudine) that represents an inappropriate risk to the patient or likely would compromise achievement of the primary study objective; patients should be closely monitored when given bortezomib in combination with the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers
  • Pregnant women are excluded from this study; breastfeeding should be discontinued
  • Active concurrent malignancy, except adequately treated non-melanoma skin cancer

Key Trial Info

Start Date :

July 9 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2017

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT00703664

Start Date

July 9 2008

End Date

December 1 2017

Last Update

August 7 2018

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

2

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

3

Northwestern University

Chicago, Illinois, United States, 60611

4

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637