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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Favrille
Study ID
NCT00324831
Phase
PHASE3
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • autologous immunoglobulin idiotype-KLH conjugate vaccine — DRUG
  • cyclophosphamide — DRUG
  • doxorubicin hydrochloride — DRUG
  • prednisone — DRUG
  • rituximab — DRUG
  • sargramostim — DRUG
  • vincristine — DRUG
  • 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 — PROCEDURE

Study Details

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.

Key Dates

Status verified
Mar 2007

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Disease-free survival as measured by the Kaplan-Meier method at 3 years

Locations (2)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90211-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-

Find similar trials in Beverly Hills, CA

By research site
Tower Cancer Research Foundation· Beverly Hills, CALineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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