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

NCT ID: NCT00182637

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2010-09-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bortezomib

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Interventions

bortezomib

Intervention Type: DRUG

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 < 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren C. Pinter-Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0405014-02

Identifier Type: -

Identifier Source: secondary_id

MILLENNIUM-VEL-04-103

Identifier Type: -

Identifier Source: secondary_id

CDR0000439458

Identifier Type: -

Identifier Source: org_study_id