Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
Study Details
Study Description
Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES: I. Determine the response rate in previously treated and previously untreated patients with Waldenstrom's macroglobulinemia receiving rituximab. II. Determine the associated toxicities with this treatment, specifically the frequency of febrile or hypotensive events, in this patient population.
OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients with prior treatment are further stratified according to type of treatment (alkylating agents vs purine nucleoside analogues). Patients receive rituximab IV over 4 hours on days 1, 8, 15, and 22. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 66 patients (33 per stratum) will be accrued for this study within 36 months.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Waldenstrom's macroglobulinemia confirmed by the following: Bone marrow lymphoplasmacytosis with: Greater than 10% lymphoplasmacytic cells OR Aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND Measurable disease defined as quantitative IgM monoclonal protein greater than 1,000 mg/dL Bone marrow lymphoplasmacytosis and beta-2 microglobulin in the serum are not considered measurable Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma Hemoglobin less than 11 g/dL OR Serum viscosity level relative to water greater than 4.0 Symptomatic with clinically significant anemia (less than 11 g/dL), bulky lymphadenopathy that is symptomatic, or symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, retinal hemorrhage)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT less than 3 times upper limit of normal Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No myocardial infarction within past 6 months No significant arrhythmia within past 3 months Hypertension allowed provided controlled with medication Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Concurrent reversible complications (e.g., hyperuricemia, hyperviscosity) allowed provided therapy for complication initiated and complications subsiding Other prior malignancies allowed provided curatively treated and currently disease free
PRIOR CONCURRENT THERAPY: No more than 2 prior regimens allowed Prior tandem transplant considered 2 prior regimens Chemotherapy prior to bone marrow transplantation as part of induction considered 1 prior regimen Retreatment with same regimen (e.g., repeated alkylating agents) considered 1 prior regimen Biologic therapy: No prior anti-CD20 therapy At least 1 month since prior epoetin alfa No concurrent epoetin alfa for 2 months after registration Chemotherapy: At least 28 days since prior alkylating agents At least 28 days since prior purine nucleoside analogues Endocrine therapy: At least 28 days since prior corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: Concurrent digoxin to control atrial fibrillation allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | United States | 85259-5404 |
| 2 | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | United States | 91010-3000 |
| 3 | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | United States | 94304 |
| 4 | Stanford University Medical Center | Stanford | California | United States | 94305-5408 |
| 5 | CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | United States | 80209-5031 |
| 6 | CCOP - Christiana Care Health Services | Wilmington | Delaware | United States | 19899 |
| 7 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 8 | Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | United States | 32608-1197 |
| 9 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612-9497 |
| 10 | Veterans Affairs Medical Center - Tampa (Haley) | Tampa | Florida | United States | 33612 |
| 11 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 12 | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | United States | 30033 |
| 13 | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | United States | 60611-3013 |
| 14 | Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | United States | 60611 |
| 15 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 16 | CCOP - Evanston | Evanston | Illinois | United States | 60201 |
| 17 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61602 |
| 18 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 19 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5289 |
| 20 | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | United States | 46202 |
| 21 | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | United States | 52403-1206 |
| 22 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
| 23 | Holden Comprehensive Cancer Center at The University of Iowa | Iowa City | Iowa | United States | 52242-1009 |
| 24 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 25 | CCOP - Ochsner | New Orleans | Louisiana | United States | 70121 |
| 26 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
| 27 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 28 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 29 | CCOP - Kalamazoo | Kalamazoo | Michigan | United States | 49007-3731 |
| 30 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
| 31 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 32 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 33 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 34 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 35 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68131 |
| 36 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 37 | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | United States | 07018-1095 |
| 38 | CCOP - Northern New Jersey | Hackensack | New Jersey | United States | 07601 |
| 39 | Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
| 40 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
| 41 | Albert Einstein Comprehensive Cancer Center | Bronx | New York | United States | 10461 |
| 42 | MBCCOP-Our Lady of Mercy Cancer Center | Bronx | New York | United States | 10466 |
| 43 | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | United States | 11209 |
| 44 | Veterans Affairs Medical Center - New York | New York | New York | United States | 10010 |
| 45 | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | United States | 10016 |
| 46 | CCOP - Merit Care Hospital | Fargo | North Dakota | United States | 58122 |
| 47 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 48 | Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | United States | 44106 |
| 49 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 50 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
| 51 | CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | United States | 43623-3456 |
| 52 | CCOP - Sooner State | Tulsa | Oklahoma | United States | 74136 |
| 53 | Hahnemann University Hospital | Philadelphia | Pennsylvania | United States | 19102-1192 |
| 54 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 55 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
| 56 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 57 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15213-3489 |
| 58 | Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | United States | 15240 |
| 59 | Guthrie Medical Center | Sayre | Pennsylvania | United States | 18840 |
| 60 | CCOP - MainLine Health | Wynnewood | Pennsylvania | United States | 19096 |
| 61 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57105-1080 |
| 62 | Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | United States | 37212 |
| 63 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
| 64 | Veterans Affairs Medical Center - Madison | Madison | Wisconsin | United States | 53705 |
| 65 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 66 | CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | United States | 54449 |
| 67 | MBCCOP - San Juan | San Juan | Puerto Rico | 00927-5800 | |
| 68 | Veterans Affairs Medical Center - San Juan | San Juan | Puerto Rico | 00927-5800 | |
| 69 | Pretoria Academic Hospitals | Pretoria | South Africa | 0001 |
Sponsors and Collaborators
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Morie A. Gertz, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067738
- E-3A98