GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF together with vaccine therapy is more effective than giving GM-CSF together with a placebo when given after combination chemotherapy and rituximab in treating diffuse large B-cell lymphoma.

PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how well they work compared to GM-CSF and placebo when given after combination chemotherapy and rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Conditions

• Lymphoma

Interventions

DRUG

autologous immunoglobulin idiotype-KLH conjugate vaccine

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

prednisone

DRUG

rituximab

DRUG

sargramostim

DRUG

vincristine

PROCEDURE

Intervention/procedure

PROCEDURE

antibody therapy

PROCEDURE

biological therapy

PROCEDURE

chemotherapy

PROCEDURE

colony-stimulating factor therapy

PROCEDURE

cytokine therapy

PROCEDURE

monoclonal antibody therapy

PROCEDURE

non-specific immune-modulator therapy

PROCEDURE

therapeutic procedure

PROCEDURE

tumor cell derivative vaccine

PROCEDURE

vaccine therapy

Sponsors & Collaborators

• Favrille

  lead INDUSTRY

Principal Investigators

• John F. Bender, PharmD · Favrille

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Countries

• United States

Study Locations