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Status:

COMPLETED

Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Lead Sponsor:

University of Rochester

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways ...

Detailed Description

OBJECTIVES: Primary * Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochlo...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed Hodgkin's lymphoma
  • Recurrent or refractory disease after prior standard combination chemotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 1 cm by physical exam or imaging studies
  • No history of non-Hodgkin's lymphoma
  • No history of other hematological malignancy
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Platelet count ≥ 100,000/mm\^3
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or involvement by Hodgkin's lymphoma)
  • AST ≤ 3 times ULN (unless due to involvement by Hodgkin's lymphoma)
  • Renal
  • Creatinine clearance ≥ 30 mL/min
  • Cardiovascular
  • Ejection fraction ≥ 40% by MUGA or echocardiogram (in patients with a history of cardiac disease)
  • Pulmonary
  • Must not require supplemental oxygen therapy
  • Immunologic
  • No known HIV infection
  • No uncontrolled bacterial, viral, or fungal infection
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy requiring therapy
  • No peripheral neuropathy ≥ grade 2 within the past 14 days
  • No hypersensitivity to boron
  • No hypersensitivity to mannitol
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 30 days since prior monoclonal antibody therapy for Hodgkin's lymphoma
  • More than 6 months since prior autologous stem cell transplantation
  • No prior allogeneic stem cell transplantation
  • No concurrent sargramostim (GM-CSF)
  • No concurrent pegfilgrastim or filgrastim (G-CSF)
  • No concurrent interleukin-11(oprelvekin)
  • Chemotherapy
  • See Disease Characteristics
  • More than 30 days since prior chemotherapy for Hodgkin's lymphoma
  • No prior treatment with gemcitabine hydrochloride
  • Endocrine therapy
  • More than 30 days since prior corticosteroid therapy for Hodgkin's lymphoma
  • No concurrent corticosteroid therapy
  • Radiotherapy
  • More than 30 days since prior radiotherapy for Hodgkin's lymphoma
  • Other
  • No prior treatment with bortezomib
  • More than 14 days since prior investigational drugs
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00262860

    Start Date

    April 1 2005

    Last Update

    May 9 2016

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    2

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, United States, 14642