Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: denileukin diftitoxBiological: rituximab
- Registration Number
- NCT00460109
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the response rate (complete response \[CR\], unconfirmed CR, and partial response) in patients with previously untreated stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with rituximab and denileukin diftitox.
* Assess the overall survival, time-to-progression, duration of response, and time-to-new therapy in patients treated with this regimen.
Secondary
* Determine whether this regimen depletes or inhibits the function of regulatory T cells in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline; on day 1 of courses 2-4; and 1 and 4 months after completion of study treatment for research studies. Research studies include analysis of peripheral blood lymphocyte subsets expressing CD3, CD4, CD8, CD19, CD25, and CD26 by flow cytometry; quantitation of CD4+, CD25+ regulatory T cells by flow cytometry; tumor-specific γ-interferon-secreting T cells by enzyme-linked immunospot assay; tumor-specific cytotoxic T-lymphocyte activity; and immune activation by enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed periodically for up to 5 years after registration.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rituximab + denileukin diftitox denileukin diftitox Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. rituximab + denileukin diftitox rituximab Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) Up to 5 years A confirmed tumor response is defined to be either a CR, CRu or PR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.
- Secondary Outcome Measures
Name Time Method Duration of Response Up to 5 years Duration of response (DOR) is defined as the time from the date at which the patient's objective status is first noted to be either a CR, CRu or PR to the earliest date of progression. The distribution of DOR will be estimated using Kaplan-Meier methods. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.
Time to Subsequent Therapy Up to 5 years Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.
Time to Disease Progression Up to 5 years Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier. Progression is defined using the response criteria for non-Hodgkin's lymphoma, as at least a 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or non-responders, or appearance of any new lesion during or at the end of therapy.
Survival Time Up to 5 years Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Trial Locations
- Locations (164)
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸South Bend, Indiana, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Holy Family Memorial Medical Center Cancer Care Center
🇺🇸Manitowoc, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸Clive, Iowa, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Fergus Falls Medical Group, PA
🇺🇸Fergus Falls, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Adventist Medical Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States