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

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	Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Drug: prednisone Drug: rasburicase Drug: rituximab Drug: therapeutic hydrocortisone Drug: vincristine sulfate	Phase II

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

ChemIDplus related topics:

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

U.S. FDA Resources

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

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	Drug: cyclophosphamide Given IV, IT, or orally Drug: cytarabine Given IV, IT, or orally Drug: doxorubicin hydrochloride Given IV, IT, or orally Drug: filgrastim Given subcutaneously 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: rituximab 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)	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: filgrastim Given subcutaneously 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: rituximab Given IV Drug: therapeutic hydrocortisone Given IT Drug: vincristine sulfate Given IV, IT, or orally

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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 117 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

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

Study ID Numbers:	CDR0000271941, COG-ANHL01P1
First Received:	April 7, 2003
Last Updated:	October 4, 2008
ClinicalTrials.gov Identifier:	NCT00057811
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Prednisone

Leukemia, Lymphoid

Hydrocortisone

Methylprednisolone

Leucovorin

Prednisolone acetate

Cyclophosphamide

Etoposide phosphate

Small non-cleaved cell lymphoma

Lymphoma, large-cell, immunoblastic

Lymphoma, large-cell

Leukemia

Burkitt's lymphoma

Lymphoma, Large-Cell, Immunoblastic

Methotrexate

Etoposide

Lymphoma

Cytarabine

Methylprednisolone Hemisuccinate

Chronic lymphocytic leukemia

Lymphoma, Large B-Cell, Diffuse

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Cortisol succinate

Rituximab

Methylprednisolone acetate

Vincristine

Rasburicase

Doxorubicin

Folic Acid

Additional relevant MeSH terms:

Antimetabolites

Anti-Inflammatory Agents

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Reproductive Control Agents

Antibiotics, Antineoplastic

Gout Suppressants

Hormones

Neuroprotective Agents

Therapeutic Uses

Vitamins

Abortifacient Agents

Micronutrients

Dermatologic Agents

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Neoplasms by Histologic Type

Vitamin B Complex

Antineoplastic Agents, Hormonal

Immune System Diseases

Growth Substances

Mitosis Modulators

Gastrointestinal Agents

Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 07, 2008

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