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Cancer Vaccine for Ovarian Cancer

Phase < 1

Waitlist Available

Led By Matthew Block

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 107

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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My cancer diagnosis is advanced ovarian, fallopian tube, or peritoneal cancer.

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I currently show no signs of my cancer returning, based on exams and tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a heart attack less than 6 months ago or have heart failure needing constant treatment.

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My ovarian cancer is of a type that grows slowly.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I am not on any experimental drugs for my cancer.

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I have been diagnosed with an autoimmune disease.

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I do not have any uncontrolled illnesses that would affect my participation.

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I have not taken more than 5 mg of prednisone or equivalent daily in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 107

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 107

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 107 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Secondary study objectives

Overall survival (OS)

Time to disease recurrence (TDR)

Other study objectives

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 more

Awards & Highlights

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.

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.

0 / 10Eligibility criteria met