RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
recurrent adult Hodgkin's lymphoma adult nodular sclerosis Hodgkin's lymphoma adult mixed cellularity Hodgkin's lymphoma adult lymphocyte depletion Hodgkin's lymphoma	Drug: bortezomib  Procedure: enzyme inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the clinical efficacy of bortezomib, in terms of overall response rate, in patients with relapsed or refractory classical Hodgkin's lymphoma.
• Determine the time to progression and 2-year overall survival of patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 9-24 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 750/mm^3
• Platelet count ≥ 75,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 2.5 times ULN

Renal

• Creatinine ≤ 2.5 mg/dL

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• Prior stem cell transplantation allowed

Chemotherapy

• See Disease Characteristics
• No concurrent chemotherapy

Endocrine therapy

• 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

Radiotherapy

• 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

Surgery

• Not specified

Other

• Recovered from all prior treatment
• No prior bortezomib or other proteosome inhibitors

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States
New York
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States

Study chairs or principal investigators

Nancy L. Bartlett, MD,  Study Chair,  Barnes-Jewish Hospital   

Study ID Numbers:  CDR0000361745; CALGB-50206; NCT00082966
Record last reviewed:  March 2005
Last Updated:  March 10, 2005
Record first received:  May 14, 2004
ClinicalTrials.gov Identifier:  NCT00082966
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08