Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, childhood diffuse large cell lymphoma, stage I childhood large cell lymphoma, stage II childhood large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary mediastinal (thymic) large B-cell lymphoma as defined by WHO classification of lymphoid neoplasms
- Diagnosis must be based on an adequate tissue sample, such as an excisional biopsy or core-needle biopsy
- A paraffin-embedded block of well-fixed lymphoma tissue must be available
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm
No active or untreated CNS lymphoma
- A lumbar puncture is not required in the absence of neurologic symptoms
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,000/mm^3 (unless related to disease)
- Platelet count ≥ 100,000/mm^3 (unless related to disease)
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST and/or ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ejection fraction ≥ 45% by MUGA or echocardiogram
Patients with HIV infection are eligible, provided the following criteria are met:
- No evidence of co-infection with hepatitis B or C
- CD4 cell count ≥ 400/mm^3
- No evidence of resistant strains of HIV
- HIV viral load ≤ 10,000 copies HIV RNA/mL (if not on anti-HIV therapy)
- HIV viral load ≤ 50 copies HIV RNA/mL (if on anti-HIV therapy)
- No history of AIDS-defining conditions
No concurrent uncontrolled illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- No active secondary malignancy except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
No prior cytotoxic chemotherapy or rituximab
- Prior limited course of glucocorticoids allowed
- No other concurrent investigational or commercial anticancer therapies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (EPOCH-R)
Arm II (R-VACOP-B)
Patients receive rituximab IV on day 1; 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 oral prednisone twice daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive rituximab IV and doxorubicin hydrochloride IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; cyclophosphamide IV over 30 minutes on day 1 of weeks 1, 5, and 9; etoposide IV over 1 hour on day 1 and then orally on days 2 and 3 of weeks 3, 7, and 11; bleomycin sulfate IV and vincristine sulfate IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; and oral prednisone on days 1-7 of week 1 and then every other day in weeks 2-10.