Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039130

Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.

Condition	Intervention	Phase
Leukemia Lymphoma	Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: methotrexate Drug: prednisone Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia

Resource links provided by NLM:

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

Drug Information available for: Dexamethasone Cyclophosphamide Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Etoposide Citrovorum factor Dexamethasone acetate Doxiproct plus Myocet Etoposide phosphate Filgrastim Rituximab Cytarabine Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Ifosfamide Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Primary Outcome Measures:

Complete response rate [ Designated as safety issue: No ]
Progression-free and overall survival [ Designated as safety issue: No ]
Feasability and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2002
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the complete response rate in patients with previously untreated Burkitt's lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy with filgrastim (G-CSF) support.
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the feasibility and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia vs lymphoma).

Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and oral prednisone on days 1-7.
Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours daily and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2, patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4 and 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood counts recover.
Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5; oral dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and rituximab IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and 6. After course 3, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia or Burkitt's or Burkitt-like lymphoma
- L3 morphology surface IgG expression
- Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)
Previously untreated disease except hydroxyurea for leukocytosis
CNS involvement allowed
Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement must also be enrolled on CALGB-8461
Patients with Burkitt's leukemia must also be enrolled on CALGB-9665

PATIENT CHARACTERISTICS:

Age:

16 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

Creatinine no greater than 1.5 times ULN

Other:

HIV negative
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent interleukin-11

Chemotherapy:

See Disease Characteristics
No other concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy except for non-disease-related conditions (e.g., insulin for diabetes)
No concurrent steroids except for adrenal failure

Radiotherapy:

No concurrent palliative radiotherapy except whole-brain irradiation for documented CNS disease

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039130

Show 31 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

John C. Byrd, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

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

No publications provided

Responsible Party:	Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers:	CDR0000069354, CALGB-10002
Study First Received:	June 6, 2002
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00039130 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated adult acute lymphoblastic leukemia
L3 adult acute lymphoblastic leukemia
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma

stage IV adult Burkitt lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Prednisone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neoplasms, Experimental
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Etoposide
Nucleic Acid Synthesis Inhibitors
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Herpesviridae Infections
Virus Diseases
Neoplasms
DNA Virus Infections
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on November 27, 2009