Combination Chemotherapy and Rituximab in Treating Patients with Untreated Burkitt Lymphoma
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, prednisone, 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.
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) principle 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
- Platelets < 75,000
- The effects of EPOCH-R on the developing human fetus are unknown; for this reason and because chemotherapy agents are known to be teratogenic, 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
- The effects of EPOCH-R on the developing human fetus are unknown; for this reason and because chemotherapy agents are known to be teratogenic, 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
Additional locations may be listed on ClinicalTrials.gov for NCT01092182.
Locations matching your search criteria
United States
Kansas
Prairie Village
Minnesota
Saint Louis Park
Nevada
Las Vegas
PRIMARY OBJECTIVE:
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 over 30 minutes on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5. Treatment repeats every 21 days for 3 cycles (patients that are FDG-PET/CT negative after cycle 2) or 6 cycles (patients that are FDG-PET/CT positive after cycle 2) 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 cycles in the absence of disease progression or unacceptable toxicity. High risk patients who have achieved only a partial response at the completion of cycle 6 may receive up to 2 additional cycles.
After completion of study treatment, patients are followed up periodically for at least 5 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationNCI - Center for Cancer Research
Principal InvestigatorMark Jason Roschewski
- Primary ID9177
- Secondary IDsNCI-2013-00915, 10-C-0052, 100052, CDR0000669336
- ClinicalTrials.gov IDNCT01092182