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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00103142 |
Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Metastatic Cancer |
Biological: falimarev Biological: inalimarev Biological: sargramostim Biological: therapeutic autologous dendritic cells |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Estimated Enrollment: | 72 |
| Study Start Date: | February 2005 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
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 SC and ID on days 28, 56, and 84.
|
Biological: falimarev
Given subcutaneously and intradermally
Biological: inalimarev
Given subcutaneously and intradermally
Biological: therapeutic autologous dendritic cells
Given subcutaneously and intradermally
|
|
Arm II: Experimental
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.
|
Biological: falimarev
Given subcutaneously and intradermally
Biological: inalimarev
Given subcutaneously and intradermally
Biological: sargramostim
Given subcutaneously
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone complete resection of hepatic or pulmonary metastases with curative intent
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No history of autoimmune disease, including, but not limited to, any of the following:
No inflammatory bowel conditions, including, but not limited to, the following:
No acute, chronic, or exfoliative skin disorders, including any of the following:
Other
Able to avoid close contact or household contact for 3 weeks after each vaccination with the following individuals:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Study Chair: | Michael A. Morse, MD | Duke University |
More Information
| Responsible Party: | Duke Comprehensive Cancer Center ( Michael A. Morse ) |
| Study ID Numbers: | CDR0000410791, DUMC-5883-04-6RO |
| Study First Received: | February 7, 2005 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00103142 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
liver metastases adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer |
adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer lung metastases |
|
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neoplasms |
Neoplastic Processes Pathologic Processes Neoplasms by Site Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |