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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

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