Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Completed · Phase 2
Conditions studied: Lymphoma
In brief
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 patients with relapsed or refractory cutaneous T-cell lymphoma.
Key facts
- Study ID
- NCT00182637
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 5
- Starts
- 2004-07-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2020-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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