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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00438880 |
Purpose
RATIONALE: Biological therapies, such as CpG 7909, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, 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 CpG 7909 together with monoclonal antibodies may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of CpG 7909 when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with non-Hodgkin's lymphoma that is recurrent or did not respond to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: agatolimod sodium Other: biomarker analysis Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: indium In 111 ibritumomab tiuxetan Radiation: yttrium Y 90 ibritumomab tiuxetan |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma |
| Estimated Enrollment: | 63 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma, including the following subtypes:
PATIENT CHARACTERISTICS:
No pre-existing clinical autoimmune or antibody-mediated diseases*, including any of the following:
PRIOR CONCURRENT 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 | |
| Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
| Investigator: | Gregory Wiseman, MD | Mayo Clinic |
| Investigator: | George J. Weiner, MD | Holden Comprehensive Cancer Center |
| Investigator: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
| Investigator: | Joseph P. Colgan, MD | Mayo Clinic |
| Investigator: | Thomas M. Habermann, MD | Mayo Clinic |
| Investigator: | David J. Inwards, MD | Mayo Clinic |
| Investigator: | Patrick Johnston, MD, PhD | Mayo Clinic |
| Investigator: | Paul Kurtin, MD | Mayo Clinic |
| Investigator: | Svetomir Markovic, MD, PhD | Mayo Clinic |
| Investigator: | Luis F. Porrata, MD | Mayo Clinic |
| Investigator: | William L. White, MD | Mayo Clinic |
| Investigator: | Ivana Micallef, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000530062, MAYO-LS0382, MAYO-IRB-703-04 |
| Study First Received: | February 20, 2007 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00438880 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult diffuse large cell lymphoma Waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent small lymphocytic lymphoma |
recurrent mantle cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |