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

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.

Conditions

• Lymphoma

Interventions

BIOLOGICAL

filgrastim

Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

BIOLOGICAL

pegfilgrastim

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

BIOLOGICAL

rituximab

375 mg/m2 IV Day 1 of each cycle

BIOLOGICAL

sargramostim

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

DRUG

cyclophosphamide

750 mg/m2 IV Day 1 of each cycle

DRUG

pegylated liposomal doxorubicin hydrochloride

40 mg/m2 IV Day 1 of each cycle

DRUG

prednisone

100 mg PO Days 1-5 of each cycle

DRUG

vincristine sulfate

1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle

OTHER

immunohistochemistry staining method

tissue specimen collected at baseline

OTHER

laboratory biomarker analysis

tissue specimen collected at baseline

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• AIDS Malignancy Consortium

  lead NETWORK

Principal Investigators

• Alexandra M. Levine, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• United States

Study Locations