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NCT Number: NCT00262860

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

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 to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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 hydrochloride.

Secondary

  • Determine the safety and toxic effects of this regimen in these patients.
  • Determine the time to progression in patients treated with this regimen.
  • Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen.

OUTLINE: This is a multicenter, pilot study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

gemcitabine hydrochloride

Drug

Primary outcomes

  1. Response Rate After 2 Courses of Therapy

    Time frame: 21 Days/course for up to 2 courses

    Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).

Secondary outcomes

  1. Change in Proteasome Activity Compared to Baseline (Cycle 1)

    Time frame: baseline to 2 hours

    Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.

  2. Change in Proteasome Activity Compared to Baseline (Cycle 2)

    Time frame: baseline and 1-2 weeks after cycle 2, day 11

    Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma

Important dates

Study start
2005
Primary completion
2008
First posted
Dec 7, 2005
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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