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Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsored by: James P. Wilmot Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262860
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: bortezomib
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate after 2 courses of therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2005
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262860

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
James P. Wilmot Cancer Center
Investigators
Principal Investigator: Jonathan W. Friedberg, MD James P. Wilmot Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000448635, URCC-U9404, URCC-RSRB-10368, MILLENNIUM-VEL-03-079, LILLY-B9E-US-X433, DFCI-04388
Study First Received: December 6, 2005
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00262860  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Bortezomib
Gemcitabine
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Recurrence

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009