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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00474929 |
Purpose
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 |
|---|---|---|
|
Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: everolimus Drug: sorafenib tosylate Other: flow cytometry Other: immunoenzyme technique Other: immunohistochemistry staining method Other: pharmacological study |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Responsible Party: | Thomas E. Witzig, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00474929 History of Changes |
| Other Study ID Numbers: | CDR0000544786, MAYO-LS0689, MAYO-07-000710 |
| Study First Received: | May 16, 2007 |
| Last Updated: | February 3, 2010 |
| 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 |
|
Neoplasms Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Everolimus Sirolimus Sorafenib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents |