Vaccine + Sargramostim for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy or radiotherapy within 4 weeks before starting the study. Also, you cannot be on systemic corticosteroid therapy within 28 days of registration.
How does the treatment Vaccine + Sargramostim for Pancreatic Cancer differ from other treatments?
This treatment is unique because it combines a vaccine with Sargramostim, which is a growth factor that stimulates the immune system, potentially enhancing the body's ability to fight pancreatic cancer. Unlike standard treatments, this approach aims to break the tumor's immune evasion by boosting T-cell responses, which are crucial for targeting and destroying cancer cells.12345
What data supports the effectiveness of the treatment Vaccine + Sargramostim for Pancreatic Cancer?
While there is no direct evidence of effectiveness for this specific treatment combination, similar vaccine approaches have shown promise. For example, a personalized mRNA vaccine led to immune responses and delayed disease recurrence in some pancreatic cancer patients, suggesting potential for vaccine-based therapies.23467
Who Is on the Research Team?
Elizabeth Poplin, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
Are You a Good Fit for This Trial?
This trial is for patients with advanced pancreatic cancer that can't be surgically removed. They should have a life expectancy of at least 6 months, good physical function, and adequate organ function. Participants must not have other serious illnesses or conditions that could interfere with the study, no recent chemotherapy or radiotherapy, no brain metastases, and they must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive falimarev vaccine intratumorally and inalimarev vaccine subcutaneously, along with sargramostim, with a dose-escalation study design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term monitoring
Participants are monitored for T cell proliferation and cytokine production
What Are the Treatments Tested in This Trial?
Interventions
- Falimarev
- Inalimarev
- Sargramostim
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor