Vaccine Therapy and Radiation to Liver Metastasis in Patients With CEA-Positive Solid Tumors
Status:
Completed
Trial end date:
2007-08-23
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effects of vaccine treatment plus radiation to the
liver in patients with solid tumors that have spread to the liver. The vaccine treatment
consists of three parts: 1) a "priming vaccine" called rV-CEA(6D)-TRICOM, made from vaccinia
virus; 2) a "boosting vaccine" called rF-CEA(6D)-TRICOM), made from fowlpox virus; and 3) a
fowlpox virus injected with DNA for GM-CSF, a chemical that boosts the immune system, called
rF-GM-CSF. Human DNA is inserted into the priming and boosting vaccine viruses to cause
production of proteins that enhance immune activity and also to produce carcinoembryonic
antigen (CEA) - a protein that is normally produced by the patient's tumor cells. The study
also uses radiation, because laboratory and animal studies show that low doses of radiation
to tumors that produce CEA make the tumor more sensitive to the effects of the vaccines.
Patients 18 years of age and older who have a solid tumor that has spread to the liver may be
eligible for this study. Candidates must have had at least one course of chemotherapy for
metastatic disease and their tumor must produce CEA. Candidates are screened with a medical
history and physical examination; blood and urine tests, test of pathology slides from
surgery to determine the presence of the CEA marker, imaging studies to assess the extent of
tumor, and an electrocardiogram (and cardiologic evaluation, if clinically indicated).
Participants receive the priming vaccination on study day 1. After 3 weeks and then again
every 2 weeks for 2 months (study days 21, 35, 49 and 63), they receive a boosting vaccine.
All vaccines are injected under the skin. With every vaccination they also receive an
injection of rF-GM-CSF to increase the number of immune cells at the vaccination site. The
day after each of the first four boosting vaccinations, patients undergo 4 consecutive days
of radiation to the tumor in the liver (study days 22-25, 36-39, 50-53 and 64-67). Patients
may continue treatment with monthly booster vaccinations (without further radiation therapy)
as long as their cancer does not get worse and they do not develop serious treatment side
effects.
Patients are monitored for safety and treatment response with the following tests and
procedures:
- Blood and urine tests and clinic visits every 2 to 4 weeks to monitor liver, kidney, and
other organ function.
- Imaging studies to assess the tumor around study day 91 and every 2 months after that
while on the study.
- Apheresis (a procedure for collecting immune cells called lymphocytes) - Apheresis is
done before the first vaccination on study day 1 and again around study day 91. For this
procedure, blood is collected through a needle in an arm vein. The blood circulates
through a machine that separates it into its components by spinning, and the lymphocytes
are extracted. The rest of the blood is returned to the patient through the same needle.
The collected lymphocytes are studied to measure the immune response to treatment.
- Liver biopsy (optional) - This test is done once before starting radiation treatment and
again around 3 to 7 days after completing the first dose of radiation. The biopsy
provides information on the type of cancer, the level of CEA produced by the tumor, and
the immune status of the tumor. For this procedure, the skin over the liver is numbed
with an anesthetic, a needle is placed in the liver tumor, and a small sample of tumor
is withdrawn through the needle.
After treatment is completed, patients are monitored for up to 15 years, including yearly
medical histories and physical examinations for 5 years following their last vaccination.
Information beyond 5 years is collected once a year by telephone