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

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: bortezomib

• Registration Number: NCT00182637
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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 patients with relapsed or refractory cutaneous T-cell lymphoma.

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.

* Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-01
• Results First Submitted: 2016-01-19
• Results First Submitted QC: 2016-01-19
• Results First Posted: 2016-02-17
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bortezomib	bortezomib	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate After 2 Courses of Treatment	2 months

Secondary Outcome Measures

Name	Time	Method
Time to Progression	2 years
Toxicity	2 years

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States