Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT ID: NCT00082966
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Given IV
Interventions
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17-N-allylamino-17-demethoxygeldanamycin/bortezomib
Given IV
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Nancy Bartlett
Role: PRINCIPAL_INVESTIGATOR
Cancer and Leukemia Group B
Locations
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Cancer and Leukemia Group B
Chicago, Illinois, United States
Countries
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Other Identifiers
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CALGB-50206
Identifier Type: -
Identifier Source: secondary_id
CDR0000361745
Identifier Type: -
Identifier Source: secondary_id
NCI-2012-01812
Identifier Type: -
Identifier Source: org_study_id