Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

Summary

Phase II trial to study the effectiveness of combining rituximab and rasburicase with combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug with rituximab may kill more cancer cells. Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of chemotherapy.

Conditions

• Childhood Burkitt Lymphoma
• Childhood Diffuse Large Cell Lymphoma
• Childhood Immunoblastic Large Cell Lymphoma
• Stage I Childhood Large Cell Lymphoma
• Stage I Childhood Small Noncleaved Cell Lymphoma
• Stage II Childhood Large Cell Lymphoma
• Stage II Childhood Small Noncleaved Cell Lymphoma
• Stage III Childhood Large Cell Lymphoma
• Stage III Childhood Small Noncleaved Cell Lymphoma
• Stage IV Childhood Large Cell Lymphoma
• Stage IV Childhood Small Noncleaved Cell Lymphoma
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

doxorubicin hydrochloride

Given IV, IT, or orally

DRUG

cyclophosphamide

Given IV

DRUG

methotrexate

Given IV or IT

DRUG

rasburicase

Given IV

DRUG

leucovorin calcium

Given IV or orally

DRUG

prednisone

Given IV or orally

DRUG

methylprednisolone

Given IV or orally

BIOLOGICAL

filgrastim

Given subcutaneously

BIOLOGICAL

rituximab

Given IV

DRUG

cytarabine

Given IT

DRUG

etoposide

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

hydrocortisone sodium succinate

Given IT

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Mitchell Cairo, MD CCRP · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-06-30

Primary Completion

2009-10-31

Completion

2014-07-31

Countries

• United States

Study Locations