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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00101010 |
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: pegylated liposomal doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
Eligibility| Ages Eligible for Study: | 61 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Arkansas | |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | |
| Fort Smith, Arkansas, United States, 72913 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Missouri | |
| Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65804 | |
| United States, New York | |
| Hematology Oncology Associates of Central New York, PC - Northeast Center | |
| East Syracuse, New York, United States, 13057-4510 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| University of Texas M.D. Anderson CCOP Research Base | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Maria A. Rodriguez, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Michael J. Fisch, University of Texas M.D. Anderson CCOP Research Base |
| ClinicalTrials.gov Identifier: | NCT00101010 History of Changes |
| Obsolete Identifiers: | NCT00290446 |
| Other Study ID Numbers: | CDR0000407533, MDA-CCOP-2004-0305, NCI-6485 |
| Study First Received: | January 7, 2005 |
| Last Updated: | May 21, 2009 |
| Health Authority: | United States: Federal Government |
|
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine |
Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones |