Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma

• Status: Withdrawn
• Trial end date: 2011-04-25
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating large B-cell lymphoma.

PURPOSE: This randomized phase II trial is studying how well rituximab and combination chemotherapy work when given with or without bleomycin sulfate in treating patients with primary mediastinal large B-cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kristie Blum; Ohio State University Comprehensive Cancer Center
• Treatments: Bleomycin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

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