Tumor Cell Vaccine in Treating Patients With Advanced Cancer
RATIONALE: Vaccines made from the patient's cancer cells may make the body build an immune response and kill their tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interferon gamma
Biological: tumor cell lysate vaccine therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE|
|Study Start Date:||August 1992|
|Study Completion Date:||May 2006|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the toxic effects and side effects associated with administration of autologous tumor cell vaccine together with adjuvant interferon gamma or sargramostim (GM-CSF) in patients with advanced cancer. II. Determine the rate of conversion of delayed tumor hypersensitivity in patients receiving subcutaneous injections of irradiated autologous tumor cells (autologous vaccine). III. Determine the effect of autologous vaccines on in vitro assays of immune antitumor activity. IV. Determine the failure free survival associated with the use of autologous tumor cell line vaccines in patients with advanced cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor type, disease stage, remission status (complete vs partial), prior therapy, progressive disease (yes vs no), and performance status (ECOG 0-1 vs 2). Patients are randomized into one of two treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor cells subcutaneously (SQ) on week 1 and then autologous tumor cell vaccine plus interferon gamma SQ on weeks 2 and 3, and then monthly beginning on week 8 and continuing until week 24. Arm II: Patients receive vaccination with irradiated autologous tumor cells as in arm I and then autologous tumor cell vaccine plus sargramostim (GM-CSF) SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24.
PROJECTED ACCRUAL: A total of 20-30 patients from each major tumor type (breast, lung, prostate, colorectal, sarcoma, renal, melanoma) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002505
|United States, California|
|Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92658|
|United States, Indiana|
|Bloomington, Indiana, United States, 47402|
|St. Vincent Hospital and Health Care Center|
|Indianapolis, Indiana, United States, 46260|
|United States, Nebraska|
|Bergan Mercy Medical Center|
|Omaha, Nebraska, United States, 68124|
|Study Chair:||Robert O. Dillman, MD, FACP||Cancer Biotherapy Research Group|