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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082966
First Posted: May 17, 2004
Last Update Posted: December 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Condition Intervention Phase
Adult Lymphocyte Depletion Hodgkin Lymphoma Adult Mixed Cellularity Hodgkin Lymphoma Adult Nodular Sclerosis Hodgkin Lymphoma Recurrent Adult Hodgkin Lymphoma Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 3 years ]
  • Time to progression [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: 2 years ]

Enrollment: 43
Study Start Date: March 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.
Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Given IV

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.

II. To assess time to progression and 2-year overall survival after bortezomib therapy.

III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed classical Hodgkin's lymphoma

    • No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
    • Core biopsies allowed if they contain adequate tissue for primary diagnosis
  • The following subtypes are allowed:

    • Nodular sclerosis
    • Lymphocyte rich
    • Mixed cellularity
    • Lymphocyte depletion
    • Classical Hodgkin's lymphoma, not otherwise specified
  • No nodular lymphocyte-predominant Hodgkin's lymphoma
  • Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
  • Measurable disease by physical exam or imaging studies

    • Any tumor mass > 1 cm is allowed
    • No non-measurable disease only, including the following:

      • Bone lesions
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Bone marrow
  • No curative option available with high-dose therapy and stem cell transplantation
  • Performance status - 0-2
  • Absolute neutrophil count ≥ 750/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Creatinine ≤ 2.5 mg/dL
  • No sensory or motor peripheral neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 3 months after study participation
  • See Disease Characteristics
  • Prior stem cell transplantation allowed
  • See Disease Characteristics
  • No concurrent chemotherapy
  • No concurrent dexamethasone or other steroidal antiemetics

    • Concurrent steroids for adrenal failure allowed
  • Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
  • Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present
  • No concurrent palliative radiotherapy
  • Recovered from all prior treatment
  • No prior bortezomib or other proteosome inhibitors
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082966


Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nancy Bartlett Cancer and Leukemia Group B
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082966     History of Changes
Other Study ID Numbers: NCI-2012-01812
CALGB-50206
CDR0000361745
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2004
First Posted: May 17, 2004
Last Update Posted: December 4, 2015
Last Verified: June 2013

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents