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

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ClinicalTrials.gov Identifier: NCT00082966
Recruitment Status : Completed
First Posted : May 17, 2004
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

May 14, 2004
May 17, 2004
December 4, 2015
March 2004
March 2007   (Final data collection date for primary outcome measure)
  • Overall response rate [ Time Frame: Up to 3 years ]
  • Time to progression [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: 2 years ]
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Complete list of historical versions of study NCT00082966 on ClinicalTrials.gov Archive Site
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Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Given IV
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.
Intervention: Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
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March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00082966
NCI-2012-01812
CALGB-50206
CDR0000361745
U10CA031946 ( U.S. NIH Grant/Contract )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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Principal Investigator: Nancy Bartlett Cancer and Leukemia Group B
National Cancer Institute (NCI)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP