Vaccine Therapy and Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Liver Metastases Due to Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00656123|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 10, 2008
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Biological: GM-K562 cell vaccine Biological: allogeneic tumor cell vaccine Drug: cyclophosphamide Genetic: gene expression analysis Genetic: protein analysis Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||February 2009|
- Safety and toxicity after course 2
- Cellular vaccine response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656123
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Clinical Research Office 410-955-8866 firstname.lastname@example.org|
|Principal Investigator:||Richard D. Schulick, MD, FACS||Sidney Kimmel Comprehensive Cancer Center|