NCT00392990
Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma
PHASE2
COMPLETED
NCT00392990
INTERVENTIONAL
A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.
DISEASE CHARACTERISTICS:
* Histologically confirmed Burkitt's or Burkitt-like non-Hodgkin's lymphoma meeting 1 of the following risk criteria:
* Low-risk disease meeting all of the following criteria:
* Normal lactate dehydrogenase level
* ECOG performance status 0-1
* Ann Arbor stage I or II
* No tumor mass over 10 cm in greatest diameter
* High-risk disease, defined as disease not meeting low-risk criteria
* Newly diagnosed disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Hemoglobin ≥ 8.0 g/dL
* Absolute neutrophil count ≥ 500/mm³
* Platelet count ≥ 100,000/mm³ (50,000/mm³ if bone marrow involvement is documented)
* AST and ALT ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
* Creatinine clearance \> 50 mL/min
* Creatinine ≤ 2.0 mg/dL
* LVEF ≥ 45% by MUGA scan or echocardiogram
* No New York Heart Association class II-IV heart failure
* No clinically significant pericardial disease
* No myocardial infarction within the past 6 months
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No ECG evidence of acute ischemia or active conduction system abnormalities
* Investigator must document any baseline ECG abnormality as not medically relevant
* No other malignancy within the past year except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
* No other serious medical or psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* Prior treatment with 1 course of any combination of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and/or prednisone\* (CHOP)-like therapy allowed, provided the following doses are not exceeded:
* Rituximab 750 mg/m²
* Cyclophosphamide 1,000 mg/m²
* Doxorubicin hydrochloride 50 mg/m²
* Vincristine 2 mg/m²
* No other investigational drugs within the past 14 days
* No other concurrent systemic, cytotoxic, investigational, or chemotherapy agents NOTE: \*No maximum dose restriction on steroids
Lymphoma
- TREATMENT
-
- Type: DRUG
- Name: Regimen A
- Description: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
- Arm Group Labels: Alternating doxil/Magrath regimen & rituximab/Magrath regimen
-
- Type: DRUG
- Name: Regimen B
- Description: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
- Arm Group Labels: Alternating doxil/Magrath regimen & rituximab/Magrath regimen
- Northwestern University