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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057811

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Drug/Agent Toxicity by Tissue/Organ Leukemia Lymphoma	Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Drug: prednisone Drug: rasburicase Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Hydrocortisone acetate Cyclophosphamide Hydrocortisone Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Etoposide Citrovorum factor Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Methylprednisolone Myocet Etoposide phosphate Filgrastim Rasburicase Rituximab Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Vincristine sulfate Cortisol succinate Cortisol 21-phosphate Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Incidence of tumor lysis syndrome [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Minimal residual disease [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2004
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FAB B: Experimental Therapies given IV, IT, orally, or subcutaneously	Biological: filgrastim Given subcutaneously Biological: rituximab Given IV Drug: cyclophosphamide Given IV, IT, or orally Drug: cytarabine Given IV, IT, or orally Drug: doxorubicin hydrochloride Given IV, IT, or orally Drug: leucovorin calcium Given IV, IT, or orally Drug: methotrexate Given IV, IT, or orally Drug: methylprednisolone Given IV, IT, or orally Drug: prednisone Given IV, IT, or orally Drug: rasburicase Given IV Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IT, or orally
FAB C: Experimental Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate)	Biological: filgrastim Given subcutaneously Biological: rituximab Given IV Drug: cyclophosphamide Given IV, IT, or orally Drug: cytarabine Given IV, IT, or orally Drug: doxorubicin hydrochloride Given IV, IT, or orally Drug: etoposide Given IV Drug: leucovorin calcium Given IV, IT, or orally Drug: methotrexate Given IV, IT, or orally Drug: methylprednisolone Given IV, IT, or orally Drug: prednisone Given IV, IT, or orally Drug: rasburicase Given IV Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IT, or orally

Arms

Assigned Interventions

FAB B: Experimental

Therapies given IV, IT, orally, or subcutaneously

Biological: filgrastim

Given subcutaneously

Biological: rituximab

Given IV

Drug: cyclophosphamide

Given IV, IT, or orally

Drug: cytarabine

Given IV, IT, or orally

Drug: doxorubicin hydrochloride

Given IV, IT, or orally

Drug: leucovorin calcium

Given IV, IT, or orally

Drug: methotrexate

Given IV, IT, or orally

Drug: methylprednisolone

Given IV, IT, or orally

Drug: prednisone

Given IV, IT, or orally

Drug: rasburicase

Given IV

Drug: therapeutic hydrocortisone

Given IT

Drug: vincristine sulfate

Given IV, IT, or orally

FAB C: Experimental

Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate)

Biological: filgrastim

Given subcutaneously

Biological: rituximab

Given IV

Drug: cyclophosphamide

Given IV, IT, or orally

Drug: cytarabine

Given IV, IT, or orally

Drug: doxorubicin hydrochloride

Given IV, IT, or orally

Drug: etoposide

Given IV

Drug: leucovorin calcium

Given IV, IT, or orally

Drug: methotrexate

Given IV, IT, or orally

Drug: methylprednisolone

Given IV, IT, or orally

Drug: prednisone

Given IV, IT, or orally

Drug: rasburicase

Given IV

Drug: therapeutic hydrocortisone

Given IT

Drug: vincristine sulfate

Given IV, IT, or orally

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 29 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed mature B-lineage (CD20-positive) leukemia or lymphoma by the REAL classification of 1 of the following subtypes:
- Diffuse large cell lymphoma
- Burkitt's lymphoma
- High-grade B-cell lymphoma (Burkitt-like)
No B-cell anaplastic large cell Ki-1 positive lymphomas and B-lymphoblastic lymphomas
One of the following FAB prognostic groups:
- Group B (intermediate risk)
- Group C (high risk)
  - Bone marrow involvement with at least 25% blasts and/or CNS involvement meeting 1 or more of the following criteria:
    - Any L3 blasts in cerebrospinal fluid
    - Cranial nerve palsy (if not explained by extracranial tumor)
    - Clinical spinal cord compression
    - Isolated intracerebral mass
    - Parameningeal extension (cranial and/or spinal) NOTE: Patients with FAB Group A disease (completely resected stage I and abdominal stage II lesions) are not eligible

NOTE: *A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

1 to 29

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Hepatitis B status known

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
No known history of congenital immune deficiency and/or laboratory evidence of acquired immune deficiency
No known G6PD deficiency (if receiving rasburicase)
No prior malignancies treated with systemic chemotherapy with alkylator or anthracycline therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

At least 1 week since prior steroids except emergency steroids initiated within 72 hours of study entry

Radiotherapy

No prior radiotherapy except emergency radiotherapy initiated within 72 hours of study entry
No concurrent radiotherapy

Surgery

No prior solid organ transplantation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057811

Show 115 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Mitchell S. Cairo, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Cairo MS, Lynch J, Harrison L, et al.: Safety, efficacy and rituximab levels following chemoimmunotherapy (rituximab + FAB chemotherapy) in children and adolescents with mature B-cell Non-Hodgkin lymphoma (B-NHL): a Children's Oncology Group report. [Abstract] Blood 112 (11): A-838, 2008.

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000271941, COG-ANHL01P1
Study First Received:	April 7, 2003
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00057811 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

drug/agent toxicity by tissue/organ
Burkitt 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
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Abortifacient Agents
Methotrexate

Dermatologic Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Hydrocortisone acetate
Leukemia, B-Cell

ClinicalTrials.gov processed this record on November 30, 2009