Could a custom vaccine help fight ovarian cancer?
NCT ID NCT02111941
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a personalized vaccine made from a patient's own immune cells to see if it is safe for people with advanced ovarian, fallopian tube, or peritoneal cancer. Nineteen participants who had already undergone surgery and chemotherapy received the vaccine. The main goal was to check for serious side effects and to see if the vaccine could stimulate an immune response against cancer cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized dendritic cell vaccine (loaded with folate receptor alpha peptides)
- What this could lead to
- If this vaccine proves safe and effective, it could offer a new way to help the immune system fight advanced ovarian cancer after standard treatments.
- What could go wrong
- This is a very early, small pilot study with only 19 participants. It primarily tests safety, not whether the vaccine actually controls the cancer. Many early-stage vaccines fail in larger trials.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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19 people
The number who actually took part.
- Started
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Apr 2014
- Finished
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Jul 2021
- 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: * Histologically confirmed surgical diagnosis of stage IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; patients with stage III cancer must have had peritoneal metastasis beyond pelvis more than 2 cm in greatest dimension and/or regional lymph node metastasis; NOTE: Histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma * Completion of cytoreductive surgery and has completed one (and only one) course of platinum-based chemotherapy (5-9 cycles) \>= 4 but =\< 20 weeks prior to registration; NOTE: cytoreductive surgery may have been prior to or after the first cycle of chemotherapy but must include hysterectomy and bilateral salpingo-oophorectomy, if the uterus and/or ovaries had not previously been removed; NOTE: patients may have had more than one chemotherapy regimen (ex: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; weekly treatment switched to every 3 week treatment due to intolerance), but may not have received a separate course of treatment for recurrent ovarian cancer (OC); NOTE: patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total 9 or fewer chemotherapy cycles * No evidence of disease at the time of registration, including no clinical concern for disease recurrence based on each of the following: * No evidence of disease by history and physical exam * Cancer antigen (CA)125 within normal limits * Computed tomography (CT) abdomen/pelvis demonstrating no radiological evidence of disease performed after completion of chemotherapy =\< 28 days before entering study * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L * Platelet count \>= 75 x 10\^9/L * Hemoglobin \>= 8.5 g/dL * Lymphocytes \>= 0.3 x 10\^9/L * Total bilirubin =\< 2 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin =\< 1.0 mg/dL * Aspartate transaminase (AST) =\< 3 x ULN * Creatinine =\< 2.0 mg/dL * Monocytes \>= 0.25 x 10\^9/L * Able to provide informed written consent * Expected survival \> 6 months * Willingness to return to Mayo Clinic Rochester for follow-up appointments * Willingness to provide blood samples for immune assessment and other tests * Willingness to undergo a tetanus vaccination Exclusion Criteria: * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Other uncontrolled intercurrent illness (specify) * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy =\< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Epithelial ovarian cancer of low malignant potential (borderline tumor) * Treatment with chemotherapy, radiation therapy, or other immunotherapy =\< 4 weeks prior to registration * Immunosuppressive therapy (excluding topical steroids) for any other condition =\< 4 weeks prior to registration * Persistent fever (\> 24 hours) documented by repeated measurement =\< 4 weeks prior to registration * Diagnosis of autoimmune disease, including, but not limited to: * Systemic lupus erythematosus (lupus) * Multiple sclerosis (MS) * Rheumatoid arthritis (RA) * Ankylosing spondylitis * Other autoimmune disease (specify) * Use of a systemic steroid (\> 5 mg prednisone daily or equivalent) =\< 4 weeks prior to registration
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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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Mayo Clinic
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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