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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00436618 |
Purpose
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Lymphoproliferative Disorder Small Intestine Cancer |
Drug: everolimus Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of RAD001 in Relapsed/Refractory Lymphoma |
| Estimated Enrollment: | 280 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma [closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma] vs indolent lymphoma [closed to accrual as of 8/18/08] vs uncommon lymphoma [closed to accrual as of 9/2/08]).
Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma.
After completion of study treatment, patients are followed periodically for up to 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven* relapsed or refractory lymphoma, including the following:
Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)
Indolent lymphoma (closed to accrual as of 8/18/08)
Uncommon lymphoma (closed to accrual as of 9/2/08)
Previously treated disease
Measurable disease** by CT scan or MRI, defined by 1 of the following:
At least 1 unidimensionally measurable lesion > 2 cm in diameter
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Concurrent stable (i.e., not increased within the past month) chronic doses of corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma)
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
| Investigator: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
| Investigator: | Han Win Tun, MD | Mayo Clinic |
| Investigator: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
| Investigator: | Irene M. Ghobrial, MD | Dana-Farber Cancer Institute |
| Investigator: | Thomas M. Habermann, MD | Mayo Clinic |
| Investigator: | David J. Inwards, MD | Mayo Clinic |
| Investigator: | Patrick Johnston, MD, PhD | Mayo Clinic |
| Investigator: | Ivana Micallef, MD | Mayo Clinic |
| Investigator: | William L. White, MD | Mayo Clinic |
| Investigator: | Scott H. Kaufmann, MD, PhD | Mayo Clinic |
| Investigator: | Joseph P. Colgan, MD | Mayo Clinic |
| Investigator: | Luis F. Porrata, MD | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic Cancer Center ( Thomas E. Witzig ) |
| Study ID Numbers: | CDR0000529824, MAYO-MC048G, MAYO-IRB-1042-05 |
| Study First Received: | February 15, 2007 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00436618 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma small intestine lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult T-cell leukemia/lymphoma recurrent grade 3 follicular lymphoma recurrent marginal zone lymphoma refractory chronic lymphocytic leukemia |
recurrent small lymphocytic lymphoma recurrent mycosis fungoides/Sezary syndrome adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult diffuse large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma primary central nervous system lymphoma post-transplant lymphoproliferative disorder recurrent adult diffuse small cleaved cell lymphoma |
|
Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Ileal Diseases Duodenal Neoplasms Leukemia Pathologic Processes Neoplasms by Site Ileal Neoplasms Jejunal Diseases Lymphoma Duodenal Diseases Jejunal Neoplasms Everolimus |
Immunoproliferative Disorders Neoplasms by Histologic Type Disease Digestive System Neoplasms Immune System Diseases Intestinal Diseases Immunosuppressive Agents Pharmacologic Actions Intestinal Neoplasms Lymphatic Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Lymphoproliferative Disorders |