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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068315 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with fludarabine with or without rituximab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine with or without rituximab in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: rituximab Drug: bortezomib Drug: fludarabine phosphate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Of PS-341 And Fludarabine For Relapsed And Refractory Indolent Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia |
| Enrollment: | 24 |
| Study Start Date: | July 2003 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV over 30 minutes on days 1-3 or 1-5. Patients may also receive rituximab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-18 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 |
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes:
Follicular lymphoma
Mantle cell lymphoma
Relapsed or refractory, progressive disease
Measurable disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 4 weeks since prior monoclonal antibody (MoAB) therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Mercy Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| Geauga Regional Hospital | |
| Chardon, Ohio, United States, 44024 | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Lake/University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| Southwest General Health Center | |
| Middleburgh Heights, Ohio, United States, 44130 | |
| UHHS Chagrin Highlands Medical Center | |
| Orange Villager, Ohio, United States, 44122 | |
| University Suburban Health Center | |
| South Euclid, Ohio, United States, 44121 | |
| UHHS Westlake Medical Center | |
| Westlaker, Ohio, United States, 44145 | |
| Principal Investigator: | Brenda W. Cooper, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Brenda Cooper, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068315 History of Changes |
| Other Study ID Numbers: | ICC3402, U01CA099168, U01CA062502, P30CA043703, CASE-CWRU-ICC-3402, NCI-6126 |
| Study First Received: | September 10, 2003 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult diffuse small cleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent mantle cell lymphoma refractory chronic lymphocytic leukemia Waldenstrom macroglobulinemia |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine monophosphate Vidarabine Fludarabine |
Rituximab Bortezomib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Antirheumatic Agents Protease Inhibitors |