Combination Chemotherapy and Rituximab in Treating Patients with Untreated Burkitt Lymphoma

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and over9177
NCI-2013-00915, 100052, CDR0000669336, 10-C-0052, NCT01092182

Trial Description

Summary

This phase II trial studies how well combination chemotherapy and rituximab works in treating patients with untreated Burkitt lymphoma. Drugs used in chemotherapy, such as etoposide, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may find cancer cells and trigger the immune system to attack them. Giving combination chemotherapy with rituximab may kill more cancer cells.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine progression free survival (PFS), event free survival (EFS) and overall survival (OS) of risk adaptive dose-adjusted (DA)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH)-with rituximab (R) in newly diagnosed Burkitt lymphoma, v-myc myelocytomatosis viral oncogene homolog (c-MYC)+ diffuse large B-cell lymphoma (DLBCL) and DA-EPOCH in c-MYC+ plasmablastic lymphoma >= 18 years.

SECONDARY OBJECTIVES:

I. Assess predictive value of early fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans on PFS.

II. Obtain pilot comparative molecular profiling of human immunodeficiency virus (HIV) negative and positive Burkitt lymphoma (BL), c-MYC+ DLBCL and c-MYC+ plasmablastic lymphoma.

III. Assess the toxicity of risk adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma, c-MYC+ DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma >= 18 years.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

GROUP I (LOW RISK PATIENTS): Patients receive rituximab intravenously (IV) on days 1 and 5; etoposide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV continuously over 96 hours on days 1-4; cyclophosphamide IV on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

GROUP II (HIGH RISK PATIENTS): Patients receive rituximab IV on day 1 and etoposide, doxorubicin hydrochloride, vincristine sulfate, cyclophosphamide, and prednisone as in Group I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. High risk patients who have achieved only a partial response at the completion of course 6 may receive up to 2 additional courses.

After completion of study treatment, patients are followed up periodically for at least 5 years.

Eligibility Criteria

Inclusion Criteria:

Patients must have Burkitt lymphoma; effective with Amendment J (version date: 06/24/2014), the following histologies were removed: B-cell lymphoma: unclassifiable with features intermediate between diffuse large B–cell lymphoma and Burkitt lymphoma; c-MYC + DLBCL and c-MYC+ plasmablastic lymphoma

If questions arise related to diagnosis, please contact the National Cancer Institute (NCI) medical advisory investigator, Dr. Mark Roschewski or the NCI study coordinator, A. Nicole Lucas

Pathology confirmed by treating institution’s pathology department

No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids, cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture

All disease stages

Human immunodeficiency virus (HIV) negative or positive

HIV positive patients on antiretroviral therapy regimen must be willing to suspend all highly active antiretroviral therapy (HAART) except in circumstances described

Eastern Cooperative Oncology Group (ECOG) 0-4

Ability of patient or durable power of attorney (DPA) for healthcare to give informed consent

Hepatitis B + patients may be enrolled at the discretion of the investigator

Exclusion Criteria:

Patients with primary central nervous system (CNS) lymphoma

Serum creatinine (Cr) > 1.5 mg/dL or creatinine clearance < 50 ml/min/1.73 m^2 unless lymphoma related

Bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated

Absolute neutrophil count (ANC) < 1000 unless lymphoma related

Platelets < 75,000 unless lymphoma related

Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study

Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential

Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion, will not be eligible to participate in the study

History of a prior invasive malignancy in past 5 years

Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year; if echocardiogram (ECHO) is obtained the left ventricular ejection fraction (LVEF) should exceed 40%

Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety

HIV positive patients with advanced immune suppression and evidence of HIV resistant to all combinations of antiretroviral therapy considered at high risk of non-lymphoma related death within 12-months due to other acquired immune deficiency syndrome (AIDS) complications should not be enrolled on the study

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
James L. Gulley, Principal Investigator

Trial Sites

U.S.A.

California
Fresno

University Oncology Associates

Uzair Bashir Chaudhary
Ph: 559-256-9680

Uzair Bashir Chaudhary
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Brian K. Link
Ph: 800-237-1225

Brian K. Link
Principal Investigator

Kansas
Prairie Village

Kansas City NCI Community Oncology Research Program

Rakesh Gaur
Ph: 913-948-5588
Email: aroland@kccop.org

Rakesh Gaur
Principal Investigator

Minnesota
Saint Louis Park

Metro Minnesota Community Oncology Research Consortium

Patrick James Flynn
Ph: 952-993-1517
Email: mmcorc@parknicollet.com

Patrick James Flynn
Principal Investigator

Nevada
Henderson

21st Century Oncology - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Southeast Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas

21st Century Oncology

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Vegas Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Shadow

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer Therapy and Integrative Medicine

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Medical Center

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Southeast

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New Jersey
Basking Ridge

Memorial Sloan Kettering Cancer Center at Basking Ridge

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

New York
Commack

Memorial Sloan Kettering Cancer Center Commack

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

Mount Sinai Hospital

Samir Sunil Parekh
Ph: 212-824-7309
Email: CCTO@mssm.edu

Samir Sunil Parekh
Principal Investigator

Rockville Centre

Memorial Sloan Kettering Cancer Center Rockville Centre

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Ariela Noy
Ph: 212-639-7202

Ariela Noy
Principal Investigator

North Carolina
Winston-Salem

Wake Forest University Health Sciences

Zanetta Stewart Lamar
Ph: 336-713-6771

Zanetta Stewart Lamar
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01092182

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.