Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
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Trial Identification
Brief Title: Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Official Title: A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma
Study ID: NCT00103142
Study Description
Brief Summary: RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.
Detailed Description: OBJECTIVES: Primary * Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF). Secondary * Compare the rate and magnitude of immune response, as determined by enzyme-linked immunosorbent spot (ELISpot), in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84. * Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87. After completion of study treatment, patients are followed for 2 years. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 2 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Contact Details
Name: Michael A. Morse, MD
Affiliation: Duke Cancer Institute
Role: STUDY_CHAIR
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