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| ID | Type | Description | Link |
|---|---|---|---|
| UCLA-0309058 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | ||
| Time to treatment failure | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Gansert, MD, PhD | Jonsson Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States | ||
| Rocky Mountain Cancer Centers - Denver Midtown |
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| Denver |
| Colorado |
| 80218 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3002 | Australia |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | ON L8N 3Z5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2C1 | Canada |
| Centre Hospitalier Lens | Lens | 62307 | France |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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