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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity after course 2
Yes
Richard D. Schulick, MD, FACS
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center
Unspecified
CDR0000589230
NCT00656123
March 2008
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |