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Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 11, 2007   Last Updated: November 13, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00460109
  Purpose

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.


Condition Intervention Phase
Lymphoma
 Biological: denileukin diftitox
Biological: rituximab
Other: flow cytometry
Other: immunoenzyme technique
Other: laboratory biomarker analysis
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Denileukin diftitox Rituximab
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of confirmed tumor response (complete response [CR], unconfirmed CR, and partial response) [ Designated as safety issue: No ]
  • Proportion of successes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to subsequent therapy [ Designated as safety issue: No ]
  • Changes in immunologic parameters [ Designated as safety issue: No ]
  • Incidence of immune responses [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: April 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

    • Stage III or IV disease
    • Grade 1 or 2 disease
  • Previously untreated disease

  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques

    • Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR > 2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging
    • Splenic enlargement may be used as a measurable parameter if the spleen is palpable ≥ 3 cm below the left costal margin
  • Circulating tumor cells < 5,000/mm³
  • Must have paraffin-embedded tissue blocks/slides available
  • No CNS lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 1 year
  • WBC ≥ 3,400/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • AST ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Albumin ≥ 3 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after completion of study therapy
  • No HIV infection
  • No other active malignancies
  • No active uncontrolled infection
  • No known hypersensitivity to denileukin diftitox or any of its components, including diphtheria toxin, aldesleukin, or excipients

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460109

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital     303-938-5253        
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80224-2522
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center     303-403-3605        
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
North Suburban Medical Center Recruiting
Thornton, Colorado, United States, 80229
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen     303-839-6000        
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Recruiting
Grand Junction, Colorado, United States, 81502
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center     719-776-5275        
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, MD     574-296-6536        
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Robin Zon, MD     574-296-6536        
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Robin Zon, MD     574-296-6536        
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Robin Zon, MD     574-296-6536        
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend     800-284-7370        
Saint Joseph Regional Medical Center Recruiting
South Bend, Indiana, United States, 46617
Contact: Robin Zon, MD     574-296-6536        
South Bend Clinic Recruiting
South Bend, Indiana, United States, 46617
Contact: Robin Zon, MD     574-296-6536        
United States, Iowa
CCOP - Iowa Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens     515-244-7586        
John Stoddard Cancer Center at Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa L     515-241-8704        
John Stoddard Cancer Center at Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M     515-241-6727        
Medical Oncology and Hematology Associates - West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens     515-875-9713        
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens     515-282-2921        
Medical Oncology and Hematology Associates at Mercy Cancer Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens     515-643-8740        
Mercy Cancer Center at Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens     515-643-8206        
Mercy Cancer Center at Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Clinical Trials Office - Mercy Cancer Center at Mercy Medical     641-422-6304        
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD     712-252-0088        
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
United States, Kansas
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Southwest Medical Center Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP     316-262-4467        
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD     734-712-1000        
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD     734-712-1000        
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute     810-762-8057        
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD     574-296-6536        
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center     517-364-2890        
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp     313-593-8090        
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD     734-712-1000        
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw     989-776-8411        
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD     734-712-1000        
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD     734-712-1000        
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD     734-712-1000        
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD     734-712-1000        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
United States, Minnesota
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD     218-786-3625        
Duluth Clinic Cancer Center - Duluth Recruiting
Duluth, Minnesota, United States, 55805-1983
Contact: Clinical Trials Office - Duluth Clinic Cancer Center - Duluth     218-786-3308        
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens     320-229-4907        
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens     320-229-4907        
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD     612-863-8585        
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital     612-625-3650        
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson     651-232-7970        
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn     612-873-5911        
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Hubert H. Humphrey Cancer Center at N     763-520-1893        
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Daniel M. Anderson     320-234-5000        
Recruiting
Alexandria, Minnesota, United States, 56308
Contact: Donald J. Jurgens     320-229-4907        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Meeker County Memorial Hospital Recruiting
Lichfield, Minnesota, United States, 55355
Contact: Clinical Trials Office - Meeker County Memorial Hospital     320-693-4520        
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD     612-863-8585        
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD     612-863-8585        
MeritCare Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen, MD     701-234-2397        
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD     218-786-3625        
Minnesota Oncology Hematology, PA - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD     612-863-8585        
Minnesota Oncology Hematology, PA - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD     612-863-8585        
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD     612-863-8585        
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center     651-254-1517        
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD     612-863-8585        
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD     612-863-8585        
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD     612-863-8585        
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute     612-863-5654        
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD     406-238-6290        
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Community Medical Center Recruiting
Missoula, Montana, United States, 59801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Guardian Oncology and Center for Wellness Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello, MD     406-238-6290        
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick     406-329-7029        
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana     406-238-6962        
Northern Montana Hospital Recruiting
Havre, Montana, United States, 59501
Contact: Benjamin T. Marchello, MD     406-238-6290        
Northern Rockies Radiation Oncology Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD     406-238-6290        
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
United States, North Dakota
Bismarck Cancer Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Edward J. Wos, DO     701-323-5741        
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD     701-234-2397        
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Edward J. Wos, DO     701-323-5741        
MeritCare Broadway Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD     701-234-2397        
Mid Dakota Clinic, PC Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Clinical Trials Office - Mid Dakota Clinic, PC     701-530-6950        
St. Alexius Medical Center Cancer Center Recruiting
Bismarck, North Dakota, United States, 58502
Contact: Clinical Trials Office - St. Alexius Medical Center Cancer Cen     701-530-6950        
United States, Ohio
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Clinical Trials Office - Adena Regional Medical Center     877-779-7585        
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Community Hospital of Springfield and Clark County Recruiting
Springfield, Ohio, United States, 45505
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Doctors Hospital at Ohio Health Recruiting
Columbus, Ohio, United States, 43228
Contact: Clinical Trials Office - Doctors Hospital at Ohio Health     614-566-3275        
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
Genesis - Good Samaritan Hospital Recruiting
Zanesville, Ohio, United States, 43701
Contact: Clinical Trials Office - Genesis - Good Samaritan Hospital     740-454-5232        
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Grant Medical Center Cancer Care Recruiting
Columbus, Ohio, United States, 43215
Contact: Clinical Trials Office - Grant Medical Center Cancer Care     614-566-4475        
Licking Memorial Cancer Care Program at Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mary Rutan Hospital Recruiting
Bellefontaine, Ohio, United States, 43311
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mercy Medical Center Recruiting
Springfield, Ohio, United States, 45504
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mount Carmel Health - West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mount Carmel St. Ann's Cancer Center Recruiting
Westerville, Ohio, United States, 43081
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Strecker Cancer Center at Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
United States, Oregon
Adventist Medical Center Recruiting
Portland, Oregon, United States, 97216
Contact: Janet C. Ruzich     503-257-2500        
CCOP - Columbia River Oncology Program Recruiting
Portland, Oregon, United States, 97225
Contact: Janet C. Ruzich     503-216-6260        
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc     503-215-6412        
Providence Milwaukie Hospital Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Janet C. Ruzich     503-513-8300        
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Clinical Trials Office - Providence St. Vincent Medical Center     503-215-6412        
United States, South Dakota
Medical X-Ray Center, PC Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Loren K. Tschetter, MD     605-328-8000        
Rapid City Regional Hospital Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Richard C. Tenglin     605-719-2360        
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Washington
Southwest Washington Medical Center Cancer Center Recruiting
Vancouver, Washington, United States, 98668
Contact: Janet C. Ruzich     360-514-2174        
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Franciscan Skemp Healthcare - La Crosse Campus Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Haleem J. Rasool     608-782-9760        
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP     920-884-3135        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Investigators
Study Chair: Stephen M. Ansell, MD, PhD Mayo Clinic
Investigator: Thomas E. Witzig, MD Mayo Clinic
Investigator: Peter T. Silberstein, MD Creighton University Medical Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000539551, NCCTG-N0682
Study First Received: April 11, 2007
Last Updated: November 13, 2009
ClinicalTrials.gov Identifier: NCT00460109     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Rituximab
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Sensory System Agents
 Analgesics, Non-Narcotic
Interleukin-2
Therapeutic Uses
Denileukin diftitox
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on November 30, 2009



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