Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

September 30, 2010

Study Completion Date

October 31, 2014

Conditions
LeukemiaLymphoma
Interventions
BIOLOGICAL

filgrastim

5 ug/kg/day sub Q injection day 7 until ANC\>5000/ul courses II-VII

BIOLOGICAL

rituximab

Day 8 course II 50 mg/sq m IV infusion: d 8 course IV \& VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion

DRUG

cyclophosphamide

200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII

DRUG

cytarabine

1 g/sq m/day IV infusion Days 4 \& 5, courses II, IV, VI

DRUG

dexamethasone

10mg/sq m PO or IV Days 1-5 courses II-VII

DRUG

doxorubicin hydrochloride

25 mg/sq m/day IV infusion Days 4 \& 5 courses III,V, VII

DRUG

etoposide

80 mg/sq m/day IV infusion Days 4 \& 5 courses II, IV, VI

DRUG

ifosfamide

800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI

DRUG

leucovorin calcium

25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX \<10nM, courses II-VII

DRUG

methotrexate

1.5 g/sq m IV infusion Day 1 courses II-VII

DRUG

prednisone

60 mg/sq m PO/day Days 1-7 course I

DRUG

vincristine sulfate

2 mg IV push Day 1 courses II-VII

DRUG

Allopurinol

300 mg/day PO Days 1-14, course I

Trial Locations (31)

11030

CCOP - North Shore University Hospital, Manhasset

Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11042

Monter Cancer Center of the North Shore-LIJ Health System, Lake Success

19713

CCOP - Christiana Care Health Services, Newark

19958

Tunnell Cancer Center at Beebe Medical Center, Lewes

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21921

Union Hospital Cancer Program at Union Hospital, Elkton

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

27710

Duke Comprehensive Cancer Center, Durham

46845

Fort Wayne Medical Oncology and Hematology, Fort Wayne

52722

Hematology Oncology Associates of the Quad Cities, Bettendorf

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

92134

Naval Medical Center - San Diego, San Diego

20307-5001

Walter Reed Army Medical Center, Washington D.C.

60612-7243

University of Illinois Cancer Center, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

52242-1002

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

14263-0001

Roswell Park Cancer Institute, Buffalo

11794-9446

Stony Brook University Cancer Center, Stony Brook

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

27157-1096

Wake Forest University Comprehensive Cancer Center, Winston-Salem

43210-1240

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

02903

Rhode Island Hospital Comprehensive Cancer Center, Providence

02906

Miriam Hospital, Providence

05602

Mountainview Medical, Berlin Corners

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

23298-0037

Virginia Commonwealth University Massey Cancer Center, Richmond

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT00039130 - Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia | Biotech Hunter | Biotech Hunter