NCT00002505

Tumor Cell Vaccine in Treating Patients With Advanced Cancer

RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Hoag Memorial Hospital Presbyterian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
BIOLOGICAL	recombinant interferon gamma
BIOLOGICAL	tumor cell lysate vaccine therapy

Timeline

• Start date: 1992-08-01
• Primary completion: 2002-08-01
• Completion: 2006-05-01
• First posted: 2004-06-28
• Last updated: 2011-05-12

Locations

4 sites across 1 country: United States