Chemotherapy |
Cancer Chemotherapy |
Clinical Trial: Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
This study is currently recruiting patients.
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have newly diagnosed Waldenstrom's macroglobulinemia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Waldenstrom's Macroglobulinemia | Drug: cyclophosphamide Drug: doxorubicin Drug: prednisone Drug: rituximab Drug: vincristine Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: monoclonal antibody therapy | Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Immune System and Disorders; Lymphatic Diseases; Vascular Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
OBJECTIVES:
- Determine the response rate of patients with newly diagnosed Waldenstrom's macroglobulinemia treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Determine the associated toxic effects of this regimen, specifically the frequency of febrile neutropenia, in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Correlate baseline cytogenetic features and gene expression profiles with response in patients treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
Patients receive rituximab IV over approximately 4 hours, cyclophosphamide IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study within approximately 6 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of bone marrow lymphoplasmacytosis with 1 of the following:
- At least 10% lymphoplasmacytic cells
- Aggregates or sheets of lymphocytes, plasma cells, or lymphoplasmacytic cells on the bone marrow biopsy
- Measurable disease, defined as a quantitative IgM monoclonal protein of at least 1,000 mg/dL
- The following indices are not considered measurable disease:
- Bone marrow lymphoplasmacytosis
- Beta-2 microglobulin in the serum
- Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following:
- Hemoglobin no greater than 11 g/dL
- Serum viscosity level relative to water of at least 4.0 centipoise
- CD-positive bone marrow or lymph node cells obtained within the past 8 weeks
- Must be symptomatic with 1 of the following:
- Clinically significant anemia (hemoglobin no greater than 11 g/dL)
- Bulky lymphadenopathy
- Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage)
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic
- Bilirubin no greater than 3.0 mg/dL
- AST no greater than 3 times upper limit of normal
- Must have been tested for hepatitis B surface antigen within the past 2 weeks
Renal
- Creatinine no greater than 3.0 mg/dL
Cardiovascular
- History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, MUGA, exercise MUGA, or coronary catheterization:
- Ejection fraction of at least 45%
- Normal fractional shortening of the left ventricle
- No active heart disease
- No myocardial infarction within the past 3 months
- No congestive heart failure
- No symptomatic ventricular arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior malignancy except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer curatively treated with surgery alone and from which patient has been disease free for at least 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy
- No prior anti-CD20 therapy
Chemotherapy
- No prior anthracyclines
Endocrine therapy
- No concurrent steroids exceeding 10 mg prednisone (or equivalent) per day
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No prior treatment for Waldenstrom's macroglobulinemia
- No concurrent dexrazoxane
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, 94304-1290, United States; Recruiting
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Veterans Affairs Medical Center - Gainesville, Gainesville, Florida, 32608-1197, United States; Recruiting
Veterans Affairs Medical Center - Miami, Miami, Florida, 33125, United States; Recruiting
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033, United States; Recruiting
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, 46202, United States; Recruiting
Iowa
Burgess Health Center, Onawa, Iowa, 51040, United States; Recruiting
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, 50316-2301, United States; Recruiting
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States; Recruiting
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231, United States; Recruiting
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417-2399, United States; Recruiting
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, 39531-2410, United States; Recruiting
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States; Recruiting
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, 68128-4157, United States; Recruiting
Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, 68105, United States; Recruiting
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, 11209, United States; Recruiting
Veterans Affairs Medical Center - New York, New York, New York, 10010, United States; Recruiting
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
North Dakota
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Pennsylvania
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting
Hahnemann University Hospital, Philadelphia, Pennsylvania, 19102-1192, United States; Recruiting
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, 15240, United States; Recruiting
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, 37212-2637, United States; Recruiting
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Virginia
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, 53705, United States; Recruiting
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, 53295, United States; Recruiting
Australia, New South Wales
Westmead Breast Centre at NSW Breast Cancer Institute, Westmead, New South Wales, 2145, Australia; Recruiting
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Puerto Rico
MBCCOP - San Juan, San Juan, 00921-3201, Puerto Rico; Recruiting
San Juan City Hospital, San Juan, 00936-7344, Puerto Rico; Recruiting
Veterans Affairs Medical Center - San Juan, San Juan, 00927-5800, Puerto Rico; Recruiting
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Rafat Abonour, MD, Study Chair, Indiana University Cancer Center
Gordon Srkalovic, MD, PhD, Study Chair, Sparrow Regional Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: December 2004
Last Updated: April 4, 2005
Record first received: May 6, 2003
ClinicalTrials.gov Identifier: NCT00060346
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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