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Status:

TERMINATED

A Phase I/II Trial of VELCADE & Gemcitabine for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

Eli Lilly and Company

Millennium Pharmaceuticals, Inc.

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may sto...

Detailed Description

OBJECTIVES: Primary * Determine the response rate (complete and partial remission) in patients with relapsed or refractory aggressive B- or T-cell non-Hodgkin's lymphoma treated with gemcitabine hyd...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of B- or T-cell non-Hodgkin's lymphoma (NHL)
  • Intermediate histology B-cell NHL, including any of the following:
  • Diffuse large B-cell lymphoma
  • Transformed large cell lymphoma
  • Any T-cell NHL histology
  • Cutaneous T-cell lymphoma (CTCL) or mycosis fungoides (MF) allowed
  • Relapsed or refractory disease, defined as disease progressed after prior complete remission (CR), partial remission (PR), or stable disease (SD) to last therapy OR failure to achieve CR, PR, or SD after completion of last therapy
  • Must have received 1-3 prior therapeutic regimens
  • Cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) AND cyclophosphamide, vincristine, and prednisone (CVP) OR CHOP with rituximab (CHOP-R) AND CVP with rituximab (CVP-R) is considered 1 regimen
  • Monoclonal antibody (e.g., rituximab) given as maintenance therapy is considered 1 regimen
  • Salvage chemotherapy followed by an autologous stem cell transplant is considered 1 regimen
  • No more than 7 prior therapeutic regimens for patients with CTCL or MF
  • No mantle cell lymphoma
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy \> 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • At least 50,000/mm\^3 if documented bone marrow involvement
  • Hemoglobin ≥ 8.0 g/dL
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Bilirubin ≤ 2 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • No known history of HIV infection
  • No other active infection
  • No uncontrolled hypertension
  • No peripheral neuropathy ≥ grade 2 within the past 2 weeks
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No acute ischemia or active conduction system abnormalities by ECG
  • No hypersensitivity to bortezomib, boron, or mannitol
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier-method contraception
  • No serious medical or psychiatric illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Prior autologous and/or allogeneic stem cell transplantation allowed
  • More than 3 weeks since prior chemotherapy, radiotherapy, or immunotherapy
  • More than 3 weeks since prior systemic biologic anticancer therapy
  • More than 3 weeks since prior systemic corticosteroids (e.g., oral prednisone \> 10 mg per day)
  • More than 2 weeks since prior investigational drug
  • No prior bortezomib or gemcitabine hydrochloride
  • No other concurrent systemic cytotoxic chemotherapy or investigational agents

Exclusion

    Key Trial Info

    Start Date :

    April 7 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 5 2012

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT00290706

    Start Date

    April 7 2006

    End Date

    September 5 2012

    Last Update

    May 28 2019

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    Northwestern University

    Chicago, Illinois, United States, 60611

    2

    Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, United States, 60611

    3

    University of Chicago Cancer Research Center

    Chicago, Illinois, United States, 60637