Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00460109
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • denileukin diftitox — BIOLOGICAL
  • rituximab — BIOLOGICAL

Study Details

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.

Key Dates

Start date
Apr 30, 2008
Status verified
Mar 2017
Primary completion
Oct 31, 2010
Completion
Mar 31, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab + 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.

Primary Outcome Measure

Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) [ Time Frame: Up to 5 years ]

Locations (165)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5499-
Aurora Presbyterian HospitalAuroraColorado80012-
Boulder Community HospitalBoulderColorado80301-9019-
Penrose Cancer Center at Penrose HospitalColorado SpringsColorado80933-
CCOP - Colorado Cancer Research ProgramDenverColorado80224-2522-
Porter Adventist HospitalDenverColorado80210-
Presbyterian - St. Luke's Medical CenterDenverColorado80218-
Rose Medical CenterDenverColorado80220-
St. Anthony Central HospitalDenverColorado80204-
St. Joseph HospitalDenverColorado80218-
Swedish Medical CenterEnglewoodColorado80110-
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand JunctionColorado81502-
North Colorado Medical CenterGreeleyColorado80631-
Sky Ridge Medical CenterLone TreeColorado80124-
Hope Cancer Care Center at Longmont United HospitalLongmontColorado80501-
McKee Medical CenterLovelandColorado80539-
St. Mary - Corwin Regional Medical CenterPuebloColorado81004-
North Suburban Medical CenterThorntonColorado80229-
Exempla Lutheran Medical CenterWheat RidgeColorado80033-
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartfordConnecticut06105-
Rush-Copley Cancer Care CenterAuroraIllinois60504-
St. Anthony's Memorial HospitalEffinghamIllinois62401-
Carle Cancer Center at Carle Foundation HospitalUrbanaIllinois61801-
CCOP - Carle Cancer CenterUrbanaIllinois61801-
Elkhart Clinic, LLCElkhartIndiana46514-2098-
Elkhart General HospitalElkhartIndiana46515-
Howard Community HospitalKokomoIndiana46904-
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa PorteIndiana46350-
Saint Anthony Memorial Health CentersMichigan CityIndiana46360-
CCOP - Northern Indiana CR ConsortiumSouth BendIndiana46601-
Memorial Hospital of South BendSouth BendIndiana46601-
Michiana Hematology-Oncology, PC - South BendSouth BendIndiana46601-
Saint Joseph Regional Medical CenterSouth BendIndiana46617-
South Bend ClinicSouth BendIndiana46617-
Medical Oncology and Hematology Associates - West Des MoinesCliveIowa50325-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa50309-
John Stoddard Cancer Center at Iowa Lutheran HospitalDes MoinesIowa50316-
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes MoinesIowa50309-
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes MoinesIowa50309-
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes MoinesIowa50314-
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes MoinesIowa50314-
Mercy Capitol HospitalDes MoinesIowa50307-
Mercy Cancer Center at Mercy Medical Center - North IowaMason CityIowa50401-
Mercy Medical Center - Sioux CitySioux CityIowa51104-
Siouxland Hematology-Oncology Associates, LLPSioux CityIowa51101-
St. Luke's Regional Medical CenterSioux CityIowa51104-
Cancer Center of Kansas, PA - ChanuteChanuteKansas66720-
Cancer Center of Kansas, PA - Dodge CityDodge CityKansas67801-
Cancer Center of Kansas, PA - El DoradoEl DoradoKansas67042-
Cancer Center of Kansas - Fort ScottFort ScottKansas66701-
Cancer Center of Kansas-IndependenceIndependenceKansas67301-
Cancer Center of Kansas, PA - KingmanKingmanKansas67068-
Lawrence Memorial HospitalLawrenceKansas66044-
Southwest Medical CenterLiberalKansas67901-
Cancer Center of Kansas, PA - NewtonNewtonKansas67114-
Cancer Center of Kansas, PA - ParsonsParsonsKansas67357-
Cancer Center of Kansas, PA - PrattPrattKansas67124-
Cancer Center of Kansas, PA - SalinaSalinaKansas67401-
Cancer Center of Kansas, PA - WellingtonWellingtonKansas67152-
Associates in Womens Health, PA - North ReviewWichitaKansas67208-
Cancer Center of Kansas, PA - Medical Arts TowerWichitaKansas67208-
Cancer Center of Kansas, PA - WichitaWichitaKansas67214-
CCOP - WichitaWichitaKansas67214-
Via Christi Cancer Center at Via Christi Regional Medical CenterWichitaKansas67214-
Cancer Center of Kansas, PA - WinfieldWinfieldKansas67156-
CCOP - Michigan Cancer Research ConsortiumAnn ArborMichigan48106-
Saint Joseph Mercy Cancer CenterAnn ArborMichigan48106-0995-
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearbornMichigan48123-2500-
Green Bay Oncology, Limited - EscanabaEscanabaMichigan49431-
Genesys Hurley Cancer InstituteFlintMichigan48503-
Hurley Medical CenterFlintMichigan48503-
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe WoodsMichigan48236-
Dickinson County Healthcare SystemIron MountainMichigan49801-
Foote Memorial HospitalJacksonMichigan49201-
Sparrow Regional Cancer CenterLansingMichigan48912-1811-
St. Mary Mercy HospitalLivoniaMichigan48154-
St. Joseph Mercy OaklandPontiacMichigan48341-2985-
Mercy Regional Cancer Center at Mercy HospitalPort HuronMichigan48060-
Seton Cancer Institute at Saint Mary's - SaginawSaginawMichigan48601-
Lakeland Regional Cancer Care Center - St. JosephSaint JosephMichigan49085-
Lakeside Cancer Specialists, PLLCSaint JosephMichigan49085-
St. John Macomb HospitalWarrenMichigan48093-
MeritCare BemidjiBemidjiMinnesota56601-
Fairview Ridges HospitalBurnsvilleMinnesota55337-
Mercy and Unity Cancer Center at Mercy HospitalCoon RapidsMinnesota55433-
CCOP - DuluthDuluthMinnesota55805-
Duluth Clinic Cancer Center - DuluthDuluthMinnesota55805-1983-
Miller - Dwan Medical CenterDuluthMinnesota55805-
Fairview Southdale HospitalEdinaMinnesota55435-
Fergus Falls Medical Group, PAFergus FallsMinnesota56537-
Mercy and Unity Cancer Center at Unity HospitalFridleyMinnesota55432-
Hutchinson Area Health CareHutchinsonMinnesota55350-
HealthEast Cancer Care at St. John's HospitalMaplewoodMinnesota55109-
Minnesota Oncology Hematology, PA - MaplewoodMaplewoodMinnesota55109-
Hennepin County Medical Center - MinneapolisMinneapolisMinnesota55415-
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolisMinnesota55407-
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdaleMinnesota55422-2900-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
Park Nicollet Cancer CenterSaint Louis ParkMinnesota55416-
Regions Hospital Cancer Care CenterSaint PaulMinnesota55101-
United HospitalSaint PaulMinnesota55102-
St. Francis Cancer Center at St. Francis Medical CenterShakopeeMinnesota55379-
Ridgeview Medical CenterWaconiaMinnesota55387-
Minnesota Oncology Hematology, PA - WoodburyWoodburyMinnesota55125-
Billings Clinic - DowntownBillingsMontana59107-7000-
CCOP - Montana Cancer ConsortiumBillingsMontana59101-
Hematology-Oncology Centers of the Northern Rockies - BillingsBillingsMontana59101-
Northern Rockies Radiation Oncology CenterBillingsMontana59101-
St. Vincent Healthcare Cancer Care ServicesBillingsMontana59101-
Bozeman Deaconess Cancer CenterBozemanMontana59715-
St. James Healthcare Cancer CareButteMontana59701-
-Great FallsMontana59405-
Great Falls Clinic - Main FacilityGreat FallsMontana59405-
Sletten Cancer Institute at Benefis HealthcareGreat FallsMontana59405-
Northern Montana HospitalHavreMontana59501-
St. Peter's HospitalHelenaMontana59601-
Glacier Oncology, PLLCKalispellMontana59901-
Kalispell Medical Oncology at KRMCKalispellMontana59901-
Community Medical CenterMissoulaMontana59801-
Guardian Oncology and Center for WellnessMissoulaMontana59804-
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoulaMontana59807-
Montana Cancer Specialists at Montana Cancer CenterMissoulaMontana59807-7877-
Bismarck Cancer CenterBismarckNorth Dakota58501-
Medcenter One Hospital Cancer Care CenterBismarckNorth Dakota58501-
Mid Dakota Clinic, PCBismarckNorth Dakota58501-
St. Alexius Medical Center Cancer CenterBismarckNorth Dakota58502-
CCOP - MeritCare HospitalFargoNorth Dakota58122-
MeritCare BroadwayFargoNorth Dakota58122-
Altru Cancer Center at Altru HospitalGrand ForksNorth Dakota58201-
Mary Rutan HospitalBellefontaineOhio43311-
Adena Regional Medical CenterChillicotheOhio45601-
CCOP - ColumbusColumbusOhio43215-
Doctors Hospital at Ohio HealthColumbusOhio43228-
Grant Medical Center Cancer CareColumbusOhio43215-
Mount Carmel Health - West HospitalColumbusOhio43222-
Riverside Methodist Hospital Cancer CareColumbusOhio43214-3998-
Grady Memorial HospitalDelawareOhio43015-
Fairfield Medical CenterLancasterOhio43130-
Strecker Cancer Center at Marietta Memorial HospitalMariettaOhio45750-
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewarkOhio43055-
Community Hospital of Springfield and Clark CountySpringfieldOhio45505-
Mercy Medical CenterSpringfieldOhio45504-
Mount Carmel St. Ann's Cancer CenterWestervilleOhio43081-
Genesis - Good Samaritan HospitalZanesvilleOhio43701-
Providence Milwaukie HospitalMilwaukieOregon97222-
Adventist Medical CenterPortlandOregon97216-
CCOP - Columbia River Oncology ProgramPortlandOregon97225-
Providence Cancer Center at Providence Portland Medical CenterPortlandOregon97213-2967-
Providence St. Vincent Medical CenterPortlandOregon97225-
Rapid City Regional HospitalRapid CitySouth Dakota57701-
Medical X-Ray Center, PCSioux FallsSouth Dakota57105-
Sanford Cancer Center at Sanford USD Medical CenterSioux FallsSouth Dakota57117-5039-
Southwest Washington Medical Center Cancer CenterVancouverWashington98668-
Green Bay Oncology, Limited at St. Mary's HospitalGreen BayWisconsin54303-
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen BayWisconsin54301-3526-
St. Mary's Hospital Medical Center - Green BayGreen BayWisconsin54303-
St. Vincent Hospital Regional Cancer CenterGreen BayWisconsin54307-3508-
Franciscan Skemp Healthcare - La Crosse CampusLa CrosseWisconsin54601-
Holy Family Memorial Medical Center Cancer Care CenterManitowocWisconsin54221-1450-
Bay Area Cancer Care Center at Bay Area Medical CenterMarinetteWisconsin54143-
Green Bay Oncology, Limited - Oconto FallsOconto FallsWisconsin54154-
Green Bay Oncology, Limited - Sturgeon BaySturgeon BayWisconsin54235-
Rocky Mountain OncologyCasperWyoming82609-
Welch Cancer Center at Sheridan Memorial HospitalSheridanWyoming82801-

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By research site
Mayo Clinic Scottsdale· Scottsdale, AZAurora Presbyterian Hospital· Aurora, COBoulder Community Hospital· Boulder, COPenrose Cancer Center at Penrose Hospital· Colorado Springs, COCCOP - Colorado Cancer Research Program· Denver, COPorter Adventist Hospital· Denver, CO

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