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| Sponsor: | Emory University |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00208975 |
Purpose
Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in which the usual survival is between 7-10 years are being asked to take part in this study. Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of patients (called complete response or complete remission), almost all will have their disease return.
In this study, researchers will test a combination of anti-cancer agents, mitoxantrone, fludarabine, rituximab and GM-CSF to see if a better and more long-lasting response can be achieved. All of the medications are approved by the Food and Drug Administration (FDA) and are available on the market. The agents we will use are:
Using GM-CSF in NHL treatment is the experimental part of this study. The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer, and to look at side effects of the treatment. They also want to determine the best dose of GM-CSF, and the best time to give rituximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Mitoxantrone, Fludarabine, Rituximab and GM-CSF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Fludarabine and Mitoxantrone, Followed by GM-CSF and Rituximab in Patients With Low Grade Non-Hodgkins Lymphoma: An Analysis of Efficacy and Tolerability |
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
|
Drug: Mitoxantrone, Fludarabine, Rituximab and GM-CSF
Patients will receive fludarabine (25 mg/m2 IV) and cyclophosphamide (250 mg/m2 IV)with sequential administration of GM-CSF (500 mu g subcutaneously) on days 6 and 7 and rituximab (375 mg/m2) on day 8. Additional doses of GM-CSF (days +8 through +14) will be given for patients to reduce variability in the regimens given for neutropenic management.
|
Patients with a low-grade, or indolent (slow-growing) form of non-Hodgkin's lymphoma (NHL) in which the usual survival is between 7-10 years are being asked to take part in this study. Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40% of patients (called complete response or complete remission), almost all will have their disease return.
When NHL is diagnosed, an abundance of white blood cells called B-lymphocytes (or B-cells) are found in the body. Almost all B-cells have a special protein on the surface called a CD20 antigen. Some anti-cancer drugs, called monoclonal antibodies, target cancer cells by binding, or "locking up", specific antigens found on their surfaces, which kills the cancer cells.
In this study, researchers will test a combination of anti-cancer agents to see if a better and more long-lasting response can be achieved. All of the medications are approved by the Food and Drug Administration (FDA) and are available on the market. The agents we will use are:
Using GM-CSF in NHL treatment is the experimental part of this study. In studies done in the laboratory, GM-CSF caused an increase in the number of antigens, such as CD20, on the surface of B-cells. If more antigens are present, it may be easier to target cells that express CD20 or other antigens. Monoclonal antibodies (such as rituximab) might then be able to more effectively bind the antigens and kill the cancer cells.
The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer, and to look at side effects of the treatment.
The researchers want to see if the laboratory results using GM-CSF (increased number of antigens on B-cells) hold true in human subjects and they also want to determine the best dose of GM-CSF and the best time to give rituximab.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher Flowers, MD | 888-946-7447 |
| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Christopher Flowers, MD | |
| Principal Investigator: | Christopher Flowers, MD | Emory University Winship Cancer Institute |
More Information
| Responsible Party: | Winship Cancer Institute ( Christopher Flowers, MD ) |
| Study ID Numbers: | 1048-2001 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00208975 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lymphoma |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Sensory System Agents Therapeutic Uses Analgesics Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Mitoxantrone Fludarabine Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Central Nervous System Agents |