Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia

Summary

RATIONALE: Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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. Giving combination chemotherapy together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.

Conditions

• Leukemia
• Lymphoma

Interventions

BIOLOGICAL

Filgrastim

5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.

BIOLOGICAL

Rituximab

375 mg/m\^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m\^2 on Day -4 of HiCy and weekly for four weeks after HiCy.

DRUG

Cyclophosphamide

1500 mg/m\^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.

DRUG

Cytarabine

100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

DRUG

Methotrexate

3 g/m\^2 on Day 8 of each cycle of R-CVP.

DRUG

Prednisone

100 mg on Days 1-5 of each cycle of R-CVP.

DRUG

Hydrocortisone

50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.

DRUG

Vincristine

1.4 mg/m\^2 on Day 1 of each cycle of R-CVP.

DRUG

Leucovorin

25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Yvette L. Kasamon, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2011-08-31

Completion

2013-08-31

Countries

• United States

Study Locations