PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer
Status:
Completed
Trial end date:
2018-05-31
Target enrollment:
Participant gender:
Summary
Background:
- Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1).
- The PANVAC-V (PANVAC vaccinia) priming vaccine and PANVAC-F (PANVAC fowlpox) boosting
vaccine contain human genes that cause production of CEA and MUC-1, which can be used as
a target for the immune system to attack the cancer. The vaccines also contain genes
that cause production of other proteins that enhance immune activity.
- Sargramostim is a protein that boosts the immune system.
Objectives:
- To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with
advanced cancer.
- To document the immune response to the vaccines and any anti-tumor responses that may
occur.
Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA
or MUC-1 protein
Design:
- This trial has three cohorts: the first cohort includes 10 patients with advanced
colorectal cancer and 10 to 15 patients with any advanced non-colorectal cancer that
produces either EA or mitochondrial Ca2+ uniporter 1 (MCU-1); the second cohort includes
12 patients with advanced breast cancer and the third cohort includes 14 patients with
advanced ovarian cancer.
- All patients receive PANVAC-V on study day 1, followed by PANVAC-F on days 15, 29 and 43
then every 28 days for up to 12 vaccines followed by every 3 months until disease
progression or toxicity. The vaccines are given by injection under the skin.
Sargramostim is injected at the vaccination site on the day of each vaccination and for
the next 3 days following vaccination.
- Patients whose scans show that their disease has progressed, but who are otherwise
clinically stable may revert back to monthly injections.
- Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day
71 of the study to measure the immune response to the treatment. Blood is collected
through a needle placed in one arm and directed through a cell separator machine where
the lymphocytes are extracted. The rest of the blood components are returned to the
patient through the same needle.
- Patients are monitored with frequent blood tests and periodic imaging tests (scans) to
monitor for safety and the response to treatment.