Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2011-09-01
• 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 find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.

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

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Sargramostim; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed AIDS-related B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:

• Grade III follicular large cell lymphoma

• Diffuse large B-cell lymphoma

• Immunoblastic lymphoma

• Plasmablastic lymphoma

• Primary effusion lymphoma

• Previously untreated disease

• Any stage disease

• CD20 positive disease

• Must have documented HIV infection

• Documentation may be by serology (enzyme-linked immunosorbent assay, western blot), culture, or quantitative polymerase chain reaction or branched DNA assays

• Prior documentation of HIV seropositivity allowed

• Measurable or nonmeasurable disease

• Currently receiving effective highly active anti-retroviral therapy

• No primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma

• No presence of leptomeningeal disease (positive cerebrospinal fluid for lymphoma) or presence of metastatic disease to brain, in terms of any mass lesion

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%

• Life expectancy ≥ 2 months

• Absolute granulocyte (neutrophil) count ≥ 1,000/mm³ (unless secondary to lymphomatous involvement of bone marrow)

• Platelet count ≥ 75,000/mm³ (unless secondary to lymphomatous involvement of bone marrow or due to HIV-related thrombocytopenia)

• Bilirubin ≤ 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV medications [e.g., indinavir, tenofavir, or atazanavir])

• SGOT ≤ 5 times upper limit of normal

• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min (unless secondary to renal involvement by lymphoma)

• LVEF normal by MUGA or echocardiogram

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma that does not require systemic therapy

• No serious, ongoing, nonmalignant disease or infection that would preclude study compliance, in the opinion of the investigator

• No history of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for ≥ 2 days

• No acute, intercurrent infection that would preclude study treatment

• Patients with Mycobacterium avium are eligible

• No cardiovascular problems, including any of the following:

• Myocardial infarction within the past 6 months

• New York Heart Association class II-IV heart failure

• Uncontrolled angina

• Severe uncontrolled ventricular arrhythmias

• Clinically significant pericardial disease

• ECG evidence of acute ischemic or active conduction system abnormalities.

• No shortness of breath at rest

• Arterial PO_2 ≥ 70 or pulse oximeter-derived O_2 saturation ≥ 94% on room air (unless due to lymphomatous involvement of the lungs)

• Able to comply with study and provide adequate informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior major surgery (except diagnostic surgery)

• At least 12 months since prior rituximab unless it was only given for indications other than the treatment of aggressive lymphoma

• No prior cytotoxic chemotherapy or radiotherapy for this lymphoma

• Concurrent radiotherapy, with or without steroids, for emergency conditions secondary to lymphoma (i.e., CNS tumor or cord compression) allowed

• No zidovudine or zidovudine-containing regimen (including Combivir® or Trizivir®) during and for 2 months after completion of chemotherapy

• Concurrent erythropoietin or filgrastim (G-CSF) allowed

• Growth factor therapy must be discontinued ≥ 24 hours prior to study entry