Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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. 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 one of five different combination chemotherapy regimens may kill more cancer cells.

PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Southampton NHS Foundation Trust
• Treatments: Bleomycin; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Liposomal doxorubicin; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Rituximab; Vincristine; Vindesine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary mediastinal diffuse large B-cell lymphoma

• CD20-positive disease

• Any stage of disease

• Must have a dominant mass within the anterior mediastinum

PATIENT CHARACTERISTICS:

• ANC ≥ 1.5 x 10^9/L (unless due to lymphoma)

• Platelets ≥ 100 x 10^9/L (unless due to lymphoma)

• WBC ≥ 3.0 x 10^9/L (unless due to lymphoma)

• Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma)

• AST/ALT ≤ 2.5 times ULN (unless due to lymphoma)

• Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must be fit to receive chemotherapy with curative intent

• No evidence of clinically significant cardiac disease* within the past 12 months, including any of the following:

• Symptomatic ventricular arrhythmias

• Congestive heart failure

• Myocardial infarction NOTE: * Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.

• No known HIV infection

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Able and willing to give informed consent and to undergo staging, including PET scanning

PRIOR CONCURRENT THERAPY:

• No prior treatment for lymphoma

• Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms