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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bortezomib

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate After 2 Courses of Treatment

Secondary Outcome Measures

Time to Progression
Toxicity

Full Information

First Posted
September 15, 2005
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00182637
Brief Title
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Official Title
A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bortezomib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
Overall Response Rate After 2 Courses of Treatment
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Time to Progression
Time Frame
2 years
Title
Toxicity
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren C. Pinter-Brown, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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

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