Vaccine Therapy for Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

December 28, 2023 updated by: Mayo Clinic

A Pilot Study of the Safety and Immunogenicity of Folate Receptor Alpha Peptide-Loaded Dendritic Cell Vaccination in Patients With Advanced Stage Epithelial Ovarian Cancer

This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of folate receptor alpha dendritic cell (FRalphaDC) vaccination (folate receptor alpha-peptide loaded dendritic cell vaccine).

SECONDARY OBJECTIVES:

I. Measure time to disease recurrence of patients treated with FRalphaDCs. II. Measure overall survival of patients treated with FRalphaDCs.

TERTIARY OBJECTIVES:

I. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific interleukin (IL)-17-secreting T helper (Th) cells, as determined by enzyme-linked immunosorbent spot (ELISpot).

II. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific T cells that secrete interferon (IFN)gamma, tumor necrosis factor (TNF)alpha, IL-10, and granzyme B, as determined by ELISpot.

III. Determine whether FRalphaDC vaccination induces antibodies specific for FRalpha.

IV. Determine whether FRalphaDC vaccination induces a delayed type hypersensitivity (DTH) skin reaction specific for FRalpha.

V. Measure FRalpha expression in patients' primary tumors and in tumors that recur after FRalphaDC vaccine treatment (when available).

VI. Determine whether FRalphaDC vaccination is associated with changes in peripheral blood immune cell subsets.

OUTLINE: This is a dose-escalation study.

INDUCTION PHASE: Patients receive folate receptor alpha peptide-loaded dendritic cell vaccine intradermally (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.

After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (vaccine therapy)

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.

Correlative studies
Given ID
Other Names:
  • FRaDC Vaccine
  • FRalphaDC Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame: Up to 3 weeks
If the accrual schema is completed and there are fewer than 5 patients with a DLT, the vaccination treatment will be considered safe in this patient population.
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Number of days from study registration until death due to any cause, assessed up to 5 years
The Kaplan-Meier method will be used to estimate the distribution of OS.
Number of days from study registration until death due to any cause, assessed up to 5 years
Time to disease recurrence (TDR)
Time Frame: Number of days from study registration until disease recurrence or death, assessed up to 5 years
The Kaplan-Meier method will be used to estimate the distribution of TDR.
Number of days from study registration until disease recurrence or death, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FRalpha expression
Time Frame: Baseline up to week 107
Assessed using simple summary statistics (mean and 95% confidence interval.
Baseline up to week 107
Change in the number of FRalpha-specific IL-17-secreting Th cells
Time Frame: Baseline up to week 107
Assessed using simple summary statistics (mean and 95% confidence interval.
Baseline up to week 107
Change in the number of FRalpha-specific T cells that secrete IFNgamma, TNFalpha, IL-10, and granzyme B
Time Frame: Baseline up to week 107
Assessed using simple summary statistics (mean and 95% confidence interval.
Baseline up to week 107
Changes in peripheral blood immune cell subsets
Time Frame: Baseline up to week 107
Assessed using simple summary statistics (mean and 95% confidence interval.
Baseline up to week 107
DTH skin reaction specific for FRalpha.
Time Frame: Up to week 104
The percent of each category will be calculated along with a 95% confidence interval.
Up to week 104
Induction of antibodies specific for FRalpha
Time Frame: Up to week 107
The percent of each category will be calculated along with a 95% confidence interval.
Up to week 107

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Matthew S. Block, M.D., Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2014

Primary Completion (Actual)

August 18, 2017

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimated)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Fallopian Tube Carcinoma

Clinical Trials on Laboratory Biomarker Analysis

Subscribe