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Cancer Vaccine

Folate Receptor Alpha Vaccine for Ovarian Cancer

Phase 2

Recruiting

Led By Matthew S. Block, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

Age ≥ 18 years

Must not have

Co-morbid systemic illnesses or severe concurrent diseases

Prior radiation therapy for this cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Summary

This trial compares a vaccine called folate receptor alpha dendritic cells (FRαDCs) to a placebo in treating patients with advanced ovarian, fallopian tube, or peritoneal cancer.

Who is the study for?

This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer (stage III or IV). Specific eligibility criteria are not provided but typically include factors like age, overall health status, and the extent of disease progression.

What is being tested?

The trial is testing a new vaccine made from the patient's own white blood cells called FRαDCs against a placebo. The vaccine aims to boost the immune system to target and destroy tumor cells by recognizing a protein on them.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions at the injection site, flu-like symptoms, fatigue due to immune response stimulation. As it's an investigational treatment, unexpected side effects could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do heavy physical work.

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I am 18 years old or older.

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My genetic tests for BRCA1/BRCA2 show no harmful mutations.

Exclusion Criteria

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

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I do not have any severe illnesses besides my current condition.

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I have had radiation therapy for my cancer.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I have a BRCA1 or BRCA2 gene mutation.

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My condition is currently showing signs or symptoms.

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I have a serious illness that is not under control.

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I had a heart attack in the last 6 months or have heart failure needing treatment for serious irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Recurrence-free survival

Secondary study objectives

Incidence of adverse events (AEs)

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (FRalphaDCs)Experimental Treatment8 Interventions

Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive FRalphaDCs ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study.

Group II: Arm II (placebo)Placebo Group8 Interventions

Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive placebo ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

Biopsy

2014

Completed Phase 4

~1150