NCT00837174

Brief Summary

The purpose of this study is to determine the rate of response to the drugs bortezomib (Velcade) and vorinostat (Zolinza), when used in combination, in patients with relapsed (recurrent) and/or refractory (difficult to treat) non-Hodgkin Lymphoma, and to determine the safety and tolerability of this regimen.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.9 years

First QC Date

February 3, 2009

Last Update Submit

September 15, 2017

Conditions

Non-Hodgkin Lymphoma

Keywords

non-Hodgkin Lymphomaaggressive lymphomaindolent lymphomaB cell lymphomaT cell lymphomaDiffuse large B cell lymphomaanaplastic large B cell lymphomalymphoblastic lymphomaBurkitt's lymphomatransformed follicular center cell lymphomatransformed marginal zone lymphomatransformed small lymphocytic lymphomagrade 3 follicular center cell lymphomablastic form marginal zone lymphomatransformed cutaneous T cell lymphomamycosis fungoides stage IVangioimmunoblastic lymphadenopathy-like T-cell lymphomanasal NK/T cell lymphomaperipheral T-cell lymphomasmall lymphocytic lymphomalymphoplasmacytic lymphomafollicular center cell lymphoma grade 1follicular center cell lymphoma grade 2mantle cell lymphomamarginal zone lymphomamycosis fungoides

Outcome Measures

Primary Outcomes (1)

  • Determine the response rate of this regimen in this patient population.

    6 cycles

Secondary Outcomes (3)

  • Determine the progression free survival of this regimen in this patient population.

    entire length of study

  • Determine the safety and tolerability of this regimen in this patient population.

    throughout course of study

  • To correlate response rate and progression free survival with pre-treatment and post-treatment NFkB, TRAIL, cyclin D1, histone acetylation, EBV related proteins, and CTA expression.

    6 cycles

Study Arms (1)

Combination Vorinostat + Bortezomib

EXPERIMENTAL

Six cycle combination therapy with vorinostat and bortezomib.

Drug: Vorinostat in combination with Bortezomib

Interventions

Vorinostat in combination with BortezomibDRUG

Patients will be treated with oral vorinostat on days 1 through 14 followed by a 7-day rest period, for a 21-day treatment cycle for up to 6 cycles in the absence of disease progression or unacceptable toxicity. The patients will receive once-daily oral vorinostat (400 mg) with bortezomib 1.3 mg/m2 as an IV push on days 1, 4, 8, 11.

Also known as: vorinostat (Zolinza), bortezomib (Velcade)
Combination Vorinostat + Bortezomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-Hodgkin Lymphoma including small lymphocytic lymphoma, lymphoplasmacytic lymphoma, follicular center cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, diffuse large B cell lymphoma, Burkitt's lymphoma, lymphoblastic lymphoma, anaplastic large cell lymphoma, nasal NK/T cell lymphoma, mycosis fungoides/Sezary syndrome, angioimmunoblastic T-cell lymphoma and peripheral T-cell lymphomas not otherwise specified
  • Received 2 or \> prior therapies, which may include hematopoietic cell transplant (HCT)
  • Received treatment with a nucleoside analog, or an alkylating agent, an anthracycline and/or in the case of B cell lymphomas, rituximab
  • Resistant disease to 2 regimens or resistant disease to at least 1 regimen after first relapse
  • Bi-dimensionally measurable disease documented within 30 days prior to enrollment. Bidimensionally measurable disease is defined as:
  • A lymph node or tumor mass that can be accurately measured in two dimensions by CT,MRI, medical photograph (skin or oral lesion), plain X-ray, PET scan or other conventional technique and a greatest diameter of 1 cm or \>; or palpable lesions with both diameters \> 2 cm (lesion measured in 2 largest perpendicular dimensions in millimeters)
  • For the purposes of this protocol, disease should be located in an area of no prior radiation therapy or a clear progression in an area that was previously irradiated
  • Adequate organ and marrow function obtained \< or = to 14 days prior to enrollment as defined by a(n):
  • ANC \> or = to 1,000/microliter
  • Platelet count \> or = to 100,000/microliter, or \> or = to 75,000/microliter if the bone marrow is involved
  • Hemoglobin level \> or = to 9 g/dL
  • Total bilirubin \< or = to 1.5 x institutional upper limit of normality (ULN).(If abnormal, direct bilirubin less than or equal to 1.5 x institutional ULN)
  • ALT or AST \< or = to 2.5 x institutional ULN (\< or = to 5 x institutional ULN if liver involvement with lymphoma)
  • Serum creatinine \< or = to 1.5 x institutional ULN
  • Zubrod (ECOG) Performance Status of 0 or 1
  • +8 more criteria

You may not qualify if:

  • Prior investigational therapy within 3 weeks of enrollment. Investigational therapy is defined as treatment that is not approved for any indication
  • CNS metastases, as indicated by clinical symptoms,cerebral edema, requirement for corticosteroids and/or progressive growth (treated CNS metastases must be stable for greater than 2 weeks prior to enrollment)
  • Active second malignancy that requires treatment or that would interfere with assessment of response
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer with \< 5 years of documented disease-free status
  • Treatment with the following within the timeframe specified prior to enrollment:
  • Chemotherapy, radiotherapy, immunotherapy (active (such as vaccines) or passive (such as monoclonal antibodies or immunotoxins)) or major surgery \< or = to 3 weeks;
  • Nitrosourea, or mitomycin \< or = to 6 weeks
  • Radioimmunotherapy (e.g. Bexxar or Zevalin) \< or = to 12 weeks
  • Concurrent enzyme-inducing anticonvulsant agents or valproic acid in last 4 weeks
  • Prior bortezomib or any other proteasome inhibitor
  • Prior vorinostat or any other histone deacetylase inhibitor
  • Concurrent systemic corticosteroids (\<10 mg/day of prednisone or equivalent for adrenal insufficiency or acute allergic reactions allowed)
  • Uncontrolled current illness including, but not limited to:
  • Clinically or laboratory determined active infection
  • Clinically limiting congestive heart failure or ejection fraction (EF) \<45%
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, T-CellLymphoma, Large B-Cell, DiffusePrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaMycosis FungoidesLymphoma, T-Cell, PeripheralLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-Cell

Interventions

VorinostatBortezomib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-Cell, CutaneousLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic AcidsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hector A Preti, M.D.

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 5, 2009

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 19, 2017

Record last verified: 2017-09