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

Lymphoma Clinical Trial

Official title:

A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182637
• Other study ID #: CDR0000439458
• Secondary ID: UCLA-0405014-02M
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: September 2010

Study information

• Verified date: January 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate After 2 Courses of Treatment		2 months
Secondary	Time to Progression		2 years
Secondary	Toxicity		2 years