At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of colon and rectum
- ✓Complete resection of hepatic or pulmonary metastases with no evidence of gross residual disease
- ✓At least 2 months of perioperative systemic chemotherapy completed at least 1 month before enrollment
- ✓Age ≥18 years
- ✕History of autoimmune disease including inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
- ✕HIV infection (by ELISA and western blot)
- ✕Immunocompromised by disease or therapy
- ✕Allergy to eggs, vaccine components, sargramostim (GM-CSF), or prior vaccinia (smallpox) vaccination
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating falimarev, inalimarev, and 2 other interventions for Colorectal Cancer and Metastatic Cancer. Completed, enrolled 74 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
Given subcutaneously and intradermally
Given subcutaneously and intradermally
Given subcutaneously
Given subcutaneously and intradermally