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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00474929 |
RATIONALE: Sorafenib and everolimus may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib and everolimus and to see how well they work in treating patients with relapsed or refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
Condition | Intervention | Phase |
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Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: everolimus Drug: sorafenib tosylate Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of the Raf Kinase/VEGFR Inhibitor Sorafenib in Combination With the mTOR Inhibitor RAD001 (Everolimus) in Patients With Relapsed Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Multiple Myeloma |
Estimated Enrollment: | 103 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation, phase I study followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of sorafenib tosylate and everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood and bone marrow are collected periodically during the study and analyzed by flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay. Patients enrolled in phase I also undergo blood sample collection on days 8 and 15 during course 1 and on day 1 of each subsequent course for pharmacokinetic studies.
After completion of study treatment, patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 103 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 or cytologically confirmed diagnosis of 1 of the following:
Measurable disease, as defined according to diagnosis as follows:
Multiple myeloma, meeting 1 of the following criteria:
Lymphoma, meeting 1 of the following criteria:
Measurable disease by CT scan or MRI or PET/CT scan, defined as ≥ 1 lesion that has a single diameter of ≥ 2 cm OR tumor cells in the blood ≥ 5 x10^9/L
Lymphoplasmacytic lymphoma without measurable lymphadenopathy, meeting both of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior major surgery or open biopsy
No concurrent immunosuppressant therapy
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242-1002 | |
Contact: Cancer Information Service 800-237-1225 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Principal Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Principal Investigator: | Shaji K. Kumar, MD | Mayo Clinic |
Study ID Numbers: | CDR0000544786, MAYO-LS0689, MAYO-07-000710 |
Study First Received: | May 16, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00474929 |
Health Authority: | Unspecified |
recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage III multiple myeloma refractory multiple myeloma Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma 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 cutaneous B-cell non-Hodgkin lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent adult grade III lymphomatoid granulomatosis |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Mycoses Lymphomatoid granulomatosis Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hematologic Diseases |
Blood Coagulation Disorders Leukemia, B-cell, chronic Multiple Myeloma Waldenstrom Macroglobulinemia B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Blood Protein Disorders Cutaneous T-cell lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Paraproteinemias Mycosis Fungoides |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Cardiovascular Diseases |