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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00671112 |
RATIONALE: Everolimus and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with bortezomib in treating patients with relapsed or refractory mantle cell or other indolent non-Hodgkin lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: bortezomib Drug: everolimus Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase 1 Trial of the Combination of Everolimus (RAD001) and Bortezomib (VELCADE) for Relapsed or Refractory Indolent and Mantle Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 36 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral everolimus once daily or once every other day on days 4-21 in course 1 and on days 1-21 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for pharmacodynamic and pharmacokinetic studies. Baseline tumor expression of mTOR and NFkB -related proteins (i.e., pS6K, pAKT, and cREL) and FOXP3 is assessed by immunohistochemistry.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed indolent non-Hodgkin lymphoma, according to the World Health Organization (WHO)/Revised European-American Lymphoma Classification, including any of the following subtypes:
Measurable disease by radiographic criteria (≥ 2 cm by CT scan)
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled medical condition that would preclude study participation, including the following:
None of the following diabetic conditions:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 |
Principal Investigator: | Stephen D. Smith, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000594429, CASE-2407 |
Study First Received: | May 2, 2008 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00671112 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma Waldenstrom macroglobulinemia |
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma refractory hairy cell leukemia B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia |
Leukemia, Lymphoid Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma Everolimus |
Immunoproliferative Disorders Hairy Cell Leukemia Bortezomib Immunosuppressive Agents Recurrence Protease Inhibitors Lymphatic Diseases Leukemia, Hairy Cell Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia B-cell Lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Everolimus Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bortezomib Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |