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Could a custom vaccine help fight ovarian cancer?

NCT ID NCT02111941

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

19 people

The number who actually took part.

Started

Apr 2014

Finished

Jul 2021

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.