Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Favrille
Study ID
NCT00089115
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • autologous immunoglobulin idiotype-KLH conjugate vaccine — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • sargramostim — BIOLOGICAL

Study Details

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. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells. PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
Jul 31, 2004
Status verified
Feb 2006

Study Design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Time to progression after 248 patients have progressed

Locations (60)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Center at University of Alabama at BirminghamBirminghamAlabama35294-
Mayo Clinic ScottsdaleScottsdaleArizona85259-
Tower Cancer Research FoundationBeverly HillsCalifornia90211-
Rebecca and John Moores UCSD Cancer CenterLa JollaCalifornia92093-0658-
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-
Hoag Cancer Center at Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San DiegoSan DiegoCalifornia92120-
Sharp Memorial Hospital Cancer CenterSan DiegoCalifornia92123-
UCSF Comprehensive Cancer CenterSan FranciscoCalifornia94143-0324-
Stanford Cancer Center at Stanford University Medical CenterStanfordCalifornia94305-
Kaiser Permanente Medical Center - VallejoVallejoCalifornia94589-
Rocky Mountain Cancer Centers - Denver MidtownDenverColorado80218-
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer CenterNewarkDelaware19713-2055-
Lombardi Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Center for Hematology-Oncology - Boca RatonBoca RatonFlorida33486-
University of Florida Health Science Center - JacksonvilleJacksonvilleFlorida32209-
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampaFlorida33612-9497-
North Idaho Cancer CenterCoeur d'AleneIdaho83814-
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Indiana University Cancer CenterIndianapolisIndiana46202-
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas CityKansas66160-7357-
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexingtonKentucky40536-0084-
Ochsner Cancer Institute at Ochsner Clinic FoundationNew OrleansLouisiana70121-
Greater Baltimore Medical CenterBaltimoreMaryland21204-6881-
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-1379-
Josephine Ford Cancer Center at Henry Ford HospitalDetroitMichigan48202-2608-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Siteman Cancer Center at Barnes-Jewish HospitalSt LouisMissouri63110-
Montana Cancer Specialists at Montana Cancer CenterMissoulaMontana59802-
New Mexico Cancer CenterAlbuquerqueNew Mexico87109-
North Shore University HospitalManhassetNew York11030-
Beth Israel Medical Center - Philipps Ambulatory Care CenterNew YorkNew York10003-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochesterNew York14642-
Our Lady of Mercy Medical Center Comprehensive Cancer CenterThe BronxNew York10466-2604-
Comprehensive Cancer Center at Wake Forest UniversityWinston-SalemNorth Carolina27157-1082-
Mid Dakota Clinic, P. C.BismarckNorth Dakota58502-5538-
Roger Maris Cancer Center at MeritCare HospitalFargoNorth Dakota58122-
Charles M. Barrett Cancer Center at University HospitalCincinnatiOhio45219-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityClevelandOhio44106-5047-
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbusOhio43210-1240-
Cancer Institute at Oregon Health and Science UniversityPortlandOregon97239-3098-
Kaiser Permanente Medical Office - Interstate Medical Office CentralPortlandOregon97227-
Providence Cancer Center at Providence Portland Medical CenterPortlandOregon97213-
Geisinger Medical CenterDanvillePennsylvania17822-0001-
Fox Chase-Temple Cancer CenterPhiladelphiaPennsylvania19111-2497-
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburghPennsylvania15224-
Sarah Cannon Cancer Center at Centennial Medical CenterNashvilleTennessee37203-
Baylor University Medical Center - DallasDallasTexas75246-
M.D. Anderson Cancer Center at University of TexasHoustonTexas77030-4009-
Cancer Care Network of South TexasSan AntonioTexas78229-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattleWashington98104-
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakimaWashington98902-
University of Wisconsin Comprehensive Cancer CenterMadisonWisconsin53792-6164-
Marshfield Clinic - Marshfield CenterMarshfieldWisconsin54449-

Find similar trials in Birmingham, AL

Related Studies