Status:
COMPLETED
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well bortezomib works in treating patient...
Detailed Description
OBJECTIVES: * Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib....
Eligibility Criteria
Inclusion
- Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome
- Stage IB-IV disease
- Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy
- Measurable disease by radiological imaging or clinical finding
- Age Over 18
- Performance status Karnofsky 70-100%
- Hematopoietic
- WBC \> 2,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 75,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- Hepatic
- Bilirubin \< 2 times upper limit of normal (ULN)
- AST and ALT \< 3 times ULN
- Renal
- Creatinine \< 1.5 times ULN
- Creatinine clearance ≥ 30 mL/min
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 3 months since prior high-dose chemotherapy
- More than 30 days since prior and no other concurrent investigational drugs
Exclusion
- history of myelodysplastic syndromes
- evidence of CNS disease
- pregnant or nursing
- peripheral neuropathy ≥ grade 2
- hypersensitivity to bortezomib, boron, or mannitol
- serious medical condition or psychiatric illness that would preclude study participation
- concurrent immunotherapy
- concurrent chemotherapy
- concurrent steroid dose \> 10 mg/day of prednisone or its equivalent
- concurrent radiotherapy
- concurrent surgery for the malignancy
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00182637
Start Date
July 1 2004
End Date
September 1 2010
Last Update
August 3 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781