Chemoimmunotherapy + Vaccines for Recurrent Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting.In the safety phase I phase, we determined the tolerable dose of IPC-CKM. In this phase 2 we will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen. The effectiveness will be determined by rate of complete pathologic response.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or have certain allergies, you may not be eligible to participate.
Is the chemoimmunotherapy treatment for recurrent ovarian cancer safe for humans?
The treatment involving cisplatin (also known as CDDP) and carboplatin has been studied for safety in humans, showing that it can be given safely at certain doses with close monitoring. Common side effects include nausea, vomiting, and blood-related issues like low white blood cell and platelet counts, while more serious effects can include kidney and nerve damage.12345
How is the treatment of Chemoimmunotherapy + Vaccines for Recurrent Ovarian Cancer different from other treatments?
This treatment is unique because it combines chemotherapy with immunotherapy, using vaccines to target specific cancer markers, potentially enhancing the immune system's ability to fight ovarian cancer. Unlike standard treatments, it aims to personalize therapy by using vaccines that stimulate the body's immune response against cancer-specific proteins.678910
What data supports the effectiveness of the treatment Chemoimmunotherapy + Vaccines for Recurrent Ovarian Cancer?
Research shows that platinum-based drugs like cisplatin are effective in treating ovarian cancer, especially when combined with other agents. Studies have demonstrated that combinations of platinum compounds with other drugs can improve response rates and survival in ovarian cancer patients.710111213
Who Is on the Research Team?
Robert P Edwards, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for advanced stage (III-IV) ovarian, tubal, or peritoneal cancer patients who haven't had chemo before. They must be fit enough for surgery and chemotherapy without significant health issues like kidney damage or bowel obstruction. Women of childbearing age need a negative pregnancy test and must use birth control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 6-8 cycles of intensive locoregional chemoimmunotherapy with intradermal autologous αDC1 vaccines and oral celecoxib
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- CKM
- DC Vaccine
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
AIM ImmunoTech Inc.
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
University of Pittsburgh
Collaborator