Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00005601
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
  • cisplatin — DRUG
  • cytarabine — DRUG
  • dexamethasone — DRUG
  • sargramostim — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.

Key Dates

Start date
Oct 31, 2000
Status verified
Dec 2016
Primary completion
Jul 31, 2003
Completion
Feb 29, 2008

Study Design

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

Arms

  • Experimental: rituximab+dexamethasone+cisplatin+cytarabine+sargramostim
    Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Primary Outcome Measure

response [ Time Frame: Up to 5 years ]

Locations (20)

FacilityCityStateZIPSite coordinators
CCOP - Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
Mayo ClinicJacksonvilleFlorida32224-
CCOP - Illinois Oncology Research AssociationPeoriaIllinois61602-
CCOP - Cedar Rapids Oncology ProjectCedar RapidsIowa52403-1206-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa50309-1016-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
CCOP - WichitaWichitaKansas67214-3882-
CCOP - OchsnerNew OrleansLouisiana70121-
CCOP - Ann Arbor RegionalAnn ArborMichigan48106-
CCOP - DuluthDuluthMinnesota55805-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare Health PlazaSaint CloudMinnesota56303-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106-
Medcenter One Health SystemBismarckNorth Dakota58501-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
CCOP - Toledo Community HospitalToledoOhio43623-3456-
CCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001-
Rapid City Regional HospitalRapid CitySouth Dakota57709-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57104-

Find similar trials in Scottsdale, AZ

By research site
CCOP - Scottsdale Oncology Program· Scottsdale, AZMayo Clinic· Jacksonville, FLCCOP - Illinois Oncology Research Association· Peoria, ILCCOP - Cedar Rapids Oncology Project· Cedar Rapids, IACCOP - Iowa Oncology Research Association· Des Moines, IASiouxland Hematology-Oncology· Sioux City, IA

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