Cancer Vaccine for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer vaccine for individuals who have undergone surgery for pancreatic cancer. The goal is to determine if the vaccine, alone or with cyclophosphamide, is safe and effective in preventing cancer recurrence. Participants may receive the vaccine alone or with either a single dose or daily doses of cyclophosphamide. Those who have had surgery for pancreatic cancer and completed chemotherapy may qualify. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic steroid therapy within 28 days before or after the vaccine administration.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the GVAX Pancreas Vaccine, which uses specially prepared pancreatic cancer cells, has generally been well-tolerated in past studies. It can help the body's immune system fight cancer cells. Researchers are testing this vaccine both alone and with cyclophosphamide, a drug that can boost the immune response.
Studies have found that this combination can strengthen the body's ability to fight tumors. While some side effects, such as fever and tiredness, have been reported, they are usually mild. It is important to note that earlier studies have tested this vaccine with cyclophosphamide, suggesting it is reasonably safe.
Although this treatment is still under study, its presence in a later phase of trials indicates it has passed initial safety checks. This is promising for those considering participation in clinical trials.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these cancer vaccines for pancreatic cancer because they represent a novel approach to treatment. Unlike traditional treatments like chemotherapy or surgery, which directly target cancer cells or tumors, these vaccines aim to stimulate the body's immune system to recognize and attack cancer cells more effectively. The vaccines use a combination of genetically modified DNA and immune-stimulating agents like GM-CSF to enhance this immune response. This approach could potentially offer a more targeted and less toxic treatment option compared to conventional therapies.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
Research shows that the GVAX Pancreas Vaccine, used in this trial, helps the body's immune system fight cancer cells. Early results suggest that this vaccine strengthens the body's response against tumors, making it easier for the immune system to find and attack cancer cells. Some studies have found that patients receiving similar vaccines lived longer than those who did not. However, past trials in advanced pancreatic cancer have shown mixed results, with some demonstrating limited success. In this trial, participants in various treatment arms will receive the vaccine, with some arms also including cyclophosphamide, a chemotherapy drug, in the hope that this combination may more effectively treat pancreatic cancer.12367
Who Is on the Research Team?
Daniel Laheru, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for individuals who've had surgery to remove stage I or II pancreatic cancer and have completed any additional therapies at least 28 days ago. They should be in good physical condition (ECOG status of 0 or 1) with proper kidney, blood, and liver function. Women must agree to use birth control if they can have children. People with recurrent pancreatic cancer, uncontrolled health issues, recent steroid therapy, pregnancy, active infections, autoimmune diseases or other cancers within the last five years cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene, alone or in combination with cyclophosphamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
The Skip Viragh Foundation
Collaborator