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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057811
First received: April 7, 2003
Last updated: October 23, 2012
Last verified: November 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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:

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
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FAB B
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
Experimental: FAB C
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:
Goldman S, Lynch J, Harrison L, et al.: Preliminary results of the addition of rasburicase to the reduction cycle and rituximab to the induction and consolidation cycles of FAB group C chemotherapy in children and adolescents with advanced stage (bone marrow ±CNS) mature B-cell non-Hodgkin lymphoma (B-NHL): A Children's Oncology Group report . [Abstract] Blood 114 (22): A-104, 2009.
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: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT00057811     History of Changes
Other Study ID Numbers: CDR0000271941, COG-ANHL01P1
Study First Received: April 7, 2003
Last Updated: October 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
drug/agent toxicity by tissue/organ
childhood 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:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
 Rituximab
Rasburicase
Etoposide phosphate
Doxorubicin
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Vincristine
Lenograstim
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate
Prednisolone acetate

ClinicalTrials.gov processed this record on May 21, 2013