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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60606
- Cancer and Leukemia Group B
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 2 years
|
2 years
|
|
Time to progression
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Overall response rate
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Bartlett, Cancer and Leukemia Group B
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-01812
- U10CA031946 (U.S. NIH Grant/Contract)
- CALGB-50206
- CDR0000361745
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