Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
This study has been completed.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00182637
First received: September 15, 2005
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL) |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Overall response rate after 2 courses of treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 5 |
| Study Start Date: | July 2004 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: bortezomib | Drug: bortezomib |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182637
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Lauren C. Pinter-Brown, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00182637 History of Changes |
| Other Study ID Numbers: | CDR0000439458, P30CA016042, UCLA-0405014-02, MILLENNIUM-VEL-04-103 |
| Study First Received: | September 15, 2005 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013