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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00182637 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL) |
Estimated Enrollment: | 25 |
Study Start Date: | July 2004 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 |
Principal Investigator: | Lauren C. Pinter-Brown, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000439458, UCLA-0405014-02, MILLENNIUM-VEL-04-103 |
Study First Received: | September 15, 2005 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00182637 |
Health Authority: | Unspecified |
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 |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Bortezomib Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Recurrence |
Mycoses Lymphatic Diseases Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |