Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Millennium Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Bortezomib

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 < 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 Criteria:

• 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