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

Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.

Conditions

• Leukemia
• Lymphoma

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• David Rizzieri, MD · Duke University Medical Center Bone Marrow Transplant

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-05-31

Primary Completion

2010-09-30

Completion

2014-10-31

Countries

• United States

Study Locations