Phase 2
N=5
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00182637 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Overall Response Rate After 2 Courses of Treatment
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate After 2 Courses of Treatment |
— | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Toxicity |
— | — |
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 patients with relapsed or refractory cutaneous T-cell lymphoma.
Eligibility Criteria
Inclusion Criteria
- 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 10 mg/day of prednisone or its equivalent
- concurrent radiotherapy
- concurrent surgery for the malignancy
Data sourced from ClinicalTrials.gov (NCT00182637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.