Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
Overview[ - collapse ][ - ]
| 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: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia. |
|---|---|
| Condition | Lymphoma |
| Intervention | Biological: rituximab Drug: cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Vincristine |
| Phase | Phase 2 |
| Sponsor | Eastern Cooperative Oncology Group |
| Responsible Party | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier | NCT00060346 |
| First Received | May 6, 2003 |
| Last Updated | February 11, 2013 |
| Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 6, 2003 |
|---|---|
| Last Updated Date | February 11, 2013 |
| Start Date | June 2004 |
| Estimated Primary Completion Date | August 2012 |
| Current Primary Outcome Measures | Objective Response to Treatment [Time Frame: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry] [Designated as safety issue: No]Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia |
|---|---|
| Official Title | Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia |
| Brief Summary | 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: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia. |
| Detailed Description | 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 intravenously (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. ACTUAL ACCRUAL: A total of 16 patients were accrued for this study. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma |
| Intervention | Biological: rituximab Rituximab is given intravenously. The initial rate is 50 mg/hr for the 1st hour. If no toxicity, the rate may be escalated in 50 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr. If the patient experiences fever and rigors, the antibody infusion is discontinued. The severity of the side effects should be evaluated. If the symptoms improve, the infusion is continued initially at half the previous rate. Following the antibody infusion, the intravenous line should be maintained for medications as needed. If there are no complications after one hour of observation, the intravenous line may be discontinued. Other Names:
Cyclophosphamide will be given at a dosage of 750 mg/m² intravenously on day 1 of each cycle (1 cycle =21 days) for 6 cycles. Dose is based on surface area calculated based on actual body weight. The drug should be administered as a rapid IV infusion over 5 to 30 minutes. Other Names:
Doxorubicin will be given intravenously at a dosage of 50 mg/m² on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Doxorubicin should be administered as a continuous infusion into tubing of a freely flowing intravenous line for 5 -15 minutes. Avoid extravasation. Other Names:
Prednisone will be administered at 100 mg/m² orally, days 1-5 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Other Names:
Vincristine will be administered 1.4 mg/m² intravenously (Maximum dose = 2.0 mg) on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Given as IV push over 1 minute, using extravasation precautions. Other Names:
|
| Study Arm (s) | Experimental: Rituximab + CHOP Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 16 |
| Estimated Completion Date | August 2012 |
| Estimated Primary Completion Date | December 2011 |
| Eligibility Criteria | INCLUSION CRITERIA: - Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following: - Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR aggregates or sheets of one of the following: lymphocytes, plasma cells or lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior to registration) - Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal protein of > 1,000 mg/dL obtained within 4 weeks prior to registration - Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node samples obtained < 8 weeks prior to registration - 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 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 - Bilirubin no greater than 3.0 mg/dL - Aspartate aminotransferase (AST) no greater than 3 times upper limit of normal - Creatinine no greater than 3.0 mg/dL - Age of 18 and over - ECOG (Eastern Cooperative Oncology Group) performance status 0-1 - 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) - History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary catheterization: - Ejection fraction of at least 45% - Normal fractional shortening of the left ventricle - Must have been tested for hepatitis B surface antigen within 2 weeks of registration - Negative pregnancy test - Fertile patients must use effective contraception EXCLUSION CRITERIA: - Prior treatment for Waldenstrom's macroglobulinemia - Prior anti-CD20 therapy - Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day - Prior irradiation if less than 4 weeks had elapsed prior to registration and the date of last treatment - Prior anthracyclines - 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 - Active heart disease - Pregnant or nursing - Myocardial infarction within the past 3 months - Congestive heart failure - Symptomatic ventricular arrhythmia |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00060346 |
|---|---|
| Other Study ID Numbers | CDR0000301634 |
| Has Data Monitoring Committee | No |
| Information Provided By | Eastern Cooperative Oncology Group |
| Study Sponsor | Eastern Cooperative Oncology Group |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Rafat Abonour, MD Indiana University Melvin and Bren Simon Cancer Center |
| Verification Date | February 2013 |
Locations[ + expand ][ + ]
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas, United States, 72205 |
|---|---|
| Beebe Medical Center | Lewes, Delaware, United States, 19958 |
| CCOP - Christiana Care Health Services | Newark, Delaware, United States, 19713 |
| Rush-Copley Cancer Care Center | Aurora, Illinois, United States, 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois, United States, 60435 |
| CCOP - Carle Cancer Center | Urbana, Illinois, United States, 61801 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois, United States, 61801 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana, United States, 46107 |
| Elkhart General Hospital | Elkhart, Indiana, United States, 46515 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana, United States, 46202-5289 |
| William N. Wishard Memorial Hospital | Indianapolis, Indiana, United States, 46202 |
| Howard Community Hospital | Kokomo, Indiana, United States, 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana, United States, 46350 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana, United States, 46360 |
| Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana, United States, 47374 |
| Saint Joseph Regional Medical Center | South Bend, Indiana, United States, 46617 |
| Memorial Hospital of South Bend | South Bend, Indiana, United States, 46601 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana, United States, 46601 |
| McFarland Clinic, PC | Ames, Iowa, United States, 50010 |
| Genesis Medical Center - West Campus | Davenport, Iowa, United States, 52804 |
| Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa, United States, 52803 |
| John Stoddard Cancer Center | Des Moines, Iowa, United States, 50316-2301 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa, United States, 50309 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa, United States, 50314 |
| Mercy Capitol Hospital | Des Moines, Iowa, United States, 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa, United States, 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa, United States, 50314 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa, United States, 50309 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa, United States, 50401 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa, United States, 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa, United States, 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa, United States, 51104 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa, United States, 50266 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas, United States, 66720 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas, United States, 67801 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas, United States, 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas, United States, 67068 |
| Southwest Medical Center | Liberal, Kansas, United States, 67901 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas, United States, 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas, United States, 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas, United States, 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas, United States, 67042 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas, United States, 67401 |
| Cotton-O'Neil Cancer Center | Topeka, Kansas, United States, 66604 |
| St. Francis Comprehensive Cancer Center | Topeka, Kansas, United States, 66606 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas, United States, 67152 |
| CCOP - Wichita | Wichita, Kansas, United States, 67214 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas, United States, 67208 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas, United States, 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas, United States, 67203 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas, United States, 67214 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas, United States, 67156 |
| Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland, United States, 21921 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan, United States, 49017 |
| Mecosta County Medical Center | Big Rapids, Michigan, United States, 49307 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan, United States, 49503 |
| CCOP - Grand Rapids | Grand Rapids, Michigan, United States, 49503 |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan, United States, 49503 |
| Metro Health Hospital | Grand Rapids, Michigan, United States, 49506 |
| Holland Community Hospital | Holland, Michigan, United States, 49423 |
| West Michigan Cancer Center | Kalamazoo, Michigan, United States, 49007-3731 |
| Bronson Methodist Hospital | Kalamazoo, Michigan, United States, 49007 |
| Borgess Medical Center | Kalamazooaa, Michigan, United States, 49001 |
| Hackley Hospital | Muskegon, Michigan, United States, 49442 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan, United States, 49085 |
| Munson Medical Center | Traverse City, Michigan, United States, 49684 |
| MeritCare Bemidji | Bemidji, Minnesota, United States, 56601 |
| Fairview Ridges Hospital | Burnsville, Minnesota, United States, 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota, United States, 55433 |
| Fairview Southdale Hospital | Edina, Minnesota, United States, 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota, United States, 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota, United States, 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota, United States, 55355 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota, United States, 55109 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota, United States, 55109 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota, United States, 55407 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota, United States, 55415 |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota, United States, 55422-2900 |
| Mayo Clinic Cancer Center | Rochester, Minnesota, United States, 55905 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, United States, 55416 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota, United States, 55379 |
| HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota, United States, 55102 |
| Park Nicollet Cancer Center | St. Louis Park, Minnesota, United States, 55416 |
| United Hospital | St. Paul, Minnesota, United States, 55102 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota, United States, 55101 |
| Ridgeview Medical Center | Waconia, Minnesota, United States, 55387 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota, United States, 55125 |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota, United States, 55125 |
| Saint Louis University Cancer Center | Saint Louis, Missouri, United States, 63110 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana, United States, 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana, United States, 59101 |
| Billings Clinic Cancer Center | Billings, Montana, United States, 59107-5100 |
| Northern Rockies Radiation Oncology Center | Billings, Montana, United States, 59101 |
| CCOP - Montana Cancer Consortium | Billings, Montana, United States, 59101 |
| Billings Clinic - Downtown | Billings, Montana, United States, 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana, United States, 59715 |
| St. James Healthcare Cancer Care | Butte, Montana, United States, 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana, United States, 59405 |
| Great Falls Clinic | Great Falls, Montana, United States, 59405 |
| St. Peter's Hospital | Helena, Montana, United States, 59601 |
| Glacier Oncology, PLLC | Kalispell, Montana, United States, 59901 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana, United States, 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana, United States, 59901 |
| Community Medical Center | Missoula, Montana, United States, 59801 |
| Guardian Oncology and Center for Wellness | Missoula, Montana, United States, 59804 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana, United States, 59807-7877 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana, United States, 59807 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey, United States, 08822 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey, United States, 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey, United States, 08043 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey, United States, 08043 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York, United States, 10466 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York, United States, 14642 |
| Interlakes Oncology/Hematology PC | Rochester, New York, United States, 14623 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina, United States, 27534 |
| Wayne Radiation Oncology | Goldsboro, North Carolina, United States, 27534 |
| Rutherford Hospital | Rutherfordton, North Carolina, United States, 28139 |
| Wilson Medical Center | Wilson, North Carolina, United States, 27893-3428 |
| CCOP - MeritCare Hospital | Fargo, North Dakota, United States, 58122 |
| MeritCare Broadway | Fargo, North Dakota, United States, 58122 |
| Aultman Cancer Center at Aultman Hospital | Canton, Ohio, United States, 44710-1799 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, United States, 44195 |
| Samaritan North Cancer Care Center | Dayton, Ohio, United States, 45415 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio, United States, 45428 |
| CCOP - Dayton | Dayton, Ohio, United States, 45429 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio, United States, 45409 |
| Good Samaritan Hospital | Dayton, Ohio, United States, 45406 |
| Grandview Hospital | Dayton, Ohio, United States, 45405 |
| Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio, United States, 44131 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio, United States, 45429 |
| St. Rita's Medical Center | Lima, Ohio, United States, 45801 |
| Middletown Regional Hospital | Middletown, Ohio, United States, 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio, United States, 45373-1300 |
| Cleveland Clinic - Wooster | Wooster, Ohio, United States, 44691 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio, United States, 45385 |
| Geisinger Medical Center | Danville, Pennsylvania, United States, 17822-0001 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States, 17033-0850 |
| Lewistown Hospital | Lewistown, Pennsylvania, United States, 17044 |
| Geisinger Medical Group - Scenery Park | State College, Pennsylvania, United States, 16801 |
| Mount Nittany Medical Center | State College, Pennsylvania, United States, 16803 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania, United States, 18711 |
| AnMed Cancer Center | Anderson, South Carolina, United States, 29621 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina, United States, 29303 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina, United States, 29303 |
| Avera Cancer Institute | Sioux Falls, South Dakota, United States, 57105 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota, United States, 57105 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota, United States, 57117-5039 |
| Brooke Army Medical Center | Fort Sam Houston, Texas, United States, 78234 |
| Wilford Hall Medical Center | Lackland AFB, Texas, United States, 78236 |
| CCOP - Scott and White Hospital | Temple, Texas, United States, 76508 |
| Danville Regional Medical Center | Danville, Virginia, United States, 24541 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin, United States, 54601 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, United States, 82801 |