Personalized vaccine plus chemo cocktail aims to outsmart advanced ovarian cancer
NCT ID NCT02432378
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This trial tests whether adding a personalized vaccine and immune-boosting drugs to standard chemotherapy can help the body fight advanced ovarian cancer more effectively. Participants receive chemotherapy directly into the abdomen along with oral medication and injections of a vaccine made from their own immune cells. The study measures changes in immune cell activity and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin, celecoxib, interferon-alpha, rintatolimod, and autologous alpha-DC1 vaccine
- What this could lead to
- If successful, this approach could improve immune response and increase the chance of complete tumor clearance in advanced ovarian cancer.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The combination therapy may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Started
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Sep 2015
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have advanced stage (III-IV) epithelial carcinoma of ovarian, tubal, or peritoneal origin. * Histologic documentation of the original primary tumor is required via the pathology report. * Original tumor blocks from primary diagnosis biopsy will be reviewed by our study pathologist at Magee. * Patients must be receiving neoadjuvant chemotherapy * Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy * Patients must be chemonaive and receiving therapy in primary first line neoadjuvant setting * Patients must have GOG performance of 0-1 * Patients must be reasonable candidates for interval debulking surgery as well as IP platinum based combination chemotherapy regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity, or bowel obstruction. * Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study. * Patient must be willing to undergo leukapheresis * Patients must agree to appropriate clinical monitoring to receive the study regimens. * Patient must have: * Bone marrow function: * Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to CTCAE v4 grade 1. * Platelets greater than or equal to 100,000/µL; * hemoglobin greater than or equal to 8.0 g/dL. * Renal function: * creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4 grade 1. * Hepatic function: * Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1). * SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1). * Patients who have signed informed consent and authorization permitting release of personal health information. * Patients must have a GOG Performance Status of 0 or 1. * Exclusion Criteria: * Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis). * Patients with a known allergy to cisplatin or taxane chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions. Patients who are allergic to paclitaxel, can be alternatively treated with abraxane. * Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids. * Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies. * Patients with uncontrolled diseases other than cancer will be excluded. * Patients who are pregnant or nursing. * Patients who have contraindications to the use of NSAID's like chronic renal failure, coronary artery disease, or bleeding ulcers. * Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease. * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. * Patients with previous pelvic radiation therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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UPMC CancerCenter at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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