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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Conditions
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Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

Intervention / Treatment
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* Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Up to 3 years | 
| Time to progression |  | Up to 5 years | 
| Overall survival |  | 2 years |