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

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.

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