Vaccine Therapy and Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Liver Metastases Due to Colorectal Cancer
Recruitment status was: Recruiting
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with chemotherapy may be a more effective treatment for colorectal cancer.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy given together with cyclophosphamide in treating patients who have undergone surgery for liver metastases due to metastatic colorectal cancer.
Biological: GM-K562 cell vaccine
Biological: allogeneic tumor cell vaccine
Genetic: gene expression analysis
Genetic: protein analysis
Other: immunoenzyme technique
Other: immunologic technique
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Clinical Trial of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer|
- Safety and toxicity after course 2
- Cellular vaccine response
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- To evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with GM-K562 cell vaccine in sequence with an immunomodulatory dose of cyclophosphamide.
- To evaluate the feasibility of measuring T-cell responses to Ep-CAM as a potential surrogate target of vaccine-induced immune responses.
- To assess efficacy, disease-free, and overall survival in vaccinated patients.
OUTLINE: At least 1 month and no more than 3 months after the last course of adjuvant systemic chemotherapy or hepatic metastectomy, patients receive cyclophosphamide IV on day -1 and vaccine therapy comprising allogeneic colorectal carcinoma cells and K562/GM-CSF cells intradermally on day 0. Treatment repeats every month for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood is collected prior to the first vaccine administration, then one month after each (1st through 4th) immunization for correlative studies. Samples are analyzed by ELISPOT assays on peripheral blood mononuclear cells, for HLA typing and HLA-A2 expression by the standard NIH microlymphocytotoxicity test, for peptides by ELISPOT assays, and for immunologic response by other exploratory assays.
After completion of study treatment, patients are followed at 28 days and then periodically thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656123
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Richard D. Schulick, MD, FACS||Sidney Kimmel Comprehensive Cancer Center|