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Cancer Vaccine for Ovarian Cancer
Phase < 1
Waitlist Available
Led By Matthew S. Block, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed surgical diagnosis of stage IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
No evidence of disease at the time of registration, including no clinical concern for disease recurrence based on specific criteria such as no evidence of disease by history and physical exam, normal cancer antigen (CA)125 levels, and normal results from computed tomography (CT) abdomen/pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 107
Awards & highlights
Study Summary
This trial is testing a vaccine made from a person's white blood cells to see if it can help the body build an effective immune response to kill ovarian cancer cells.
Who is the study for?
This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who've had surgery and one round of chemo. They should have no signs of disease currently, be in good physical condition, able to consent, return for follow-ups at Mayo Clinic Rochester, provide blood samples, get a tetanus shot and live more than 6 months.Check my eligibility
What is being tested?
The study tests the safety and immune response to a vaccine therapy made from the patient's own white blood cells treated with peptides. It targets women with stage IIIC-IV ovarian epithelial cancer post-surgery and chemotherapy.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical vaccine-related reactions such as soreness at injection site, fever or fatigue. Since it involves the immune system there could also be risks of autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer diagnosis is advanced ovarian, fallopian tube, or peritoneal cancer.
Select...
I currently show no signs of my cancer returning, based on exams and tests.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 107
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 107
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Overall survival (OS)
Time to disease recurrence (TDR)
Other outcome measures
Change in FRalpha expression
Change in the number of FRalpha-specific IL-17-secreting Th cells
Change in the number of FRalpha-specific T cells that secrete IFNgamma, TNFalpha, IL-10, and granzyme B
+3 moreSide effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (vaccine therapy)Experimental Treatment2 Interventions
INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine ID on day 1. Treatment repeats every 3 months for 7 courses in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,765 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,134 Total Patients Enrolled
Matthew S. Block, M.D., Ph.D.Principal InvestigatorMayo Clinic
5 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 3 years.I had a heart attack less than 6 months ago or have heart failure needing constant treatment.I had surgery to reduce my tumor and finished one round of platinum-based chemotherapy between 4 to 20 weeks ago.You are willing to give blood samples for tests to check your immune system and other health factors.My ovarian cancer is of a type that grows slowly.I haven't had chemotherapy, radiation, or immunotherapy in the last 4 weeks.My cancer diagnosis is advanced ovarian, fallopian tube, or peritoneal cancer.I haven't taken any immune-weakening medication (except creams) in the last 4 weeks.I currently show no signs of my cancer returning, based on exams and tests.I am immunocompromised or HIV positive and on antiretroviral therapy.I am not on any experimental drugs for my cancer.I have had a fever for more than 24 hours within the last 4 weeks.I have been diagnosed with an autoimmune disease.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any uncontrolled illnesses that would affect my participation.I have not taken more than 5 mg of prednisone or equivalent daily in the last 4 weeks.You are expected to live for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vaccine therapy)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the efficacy of Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine been tested in previous research?
"Currently, there are 13 ongoing clinical trials of Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine with 2 in the advanced Phase 3. As many as 36 different medical facilities across Hangzhou, Zhejiang offer this vaccine to patients."
Answered by AI
How has Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine been utilized?
"By employing a Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine, clinicians may treat conditions related to nutritional depletion or vitamin shortages such as folate deficiency."
Answered by AI
How many individuals are the maximum number of participants in this experiment?
"This clinical trial is currently not enrolling patients, as per the latest update of October 7th 2022. However, there are 6396 medical studies that include participants with fallopian tubes and 13 trials for Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine recruiting at this time."
Answered by AI
Are there any vacancies available in this medical research project?
"This clinical trial is not actively enrolling patients right now. It was advertised on April 14th 2014 and last updated October 7th 2022. Nevertheless, if you're seeking other trials there are 6396 searching for people with fallopian tubes while 13 are looking to recruit participants for a Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine study."
Answered by AI
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