Status:
COMPLETED
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00082966
Start Date
March 1 2004
Last Update
December 4 2015
Active Locations (1)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606