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

Primary Purpose

Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Clear Cell Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vaccine therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
The Kaplan-Meier method will be used to estimate the distribution of OS.
Time to disease recurrence (TDR)
The Kaplan-Meier method will be used to estimate the distribution of TDR.

Full Information

First Posted
April 7, 2014
Last Updated
July 3, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02111941
Brief Title
Vaccine Therapy for Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2014 (Actual)
Primary Completion Date
August 18, 2017 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm, Fallopian Tube Transitional Cell Carcinoma, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Transitional Cell Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer, Undifferentiated Fallopian Tube Carcinoma, Undifferentiated Ovarian Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vaccine therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Biological
Intervention Name(s)
Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Other Intervention Name(s)
FRaDC Vaccine, FRalphaDC Vaccine
Intervention Description
Given ID
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Description
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.
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The Kaplan-Meier method will be used to estimate the distribution of OS.
Time Frame
Number of days from study registration until death due to any cause, assessed up to 5 years
Title
Time to disease recurrence (TDR)
Description
The Kaplan-Meier method will be used to estimate the distribution of TDR.
Time Frame
Number of days from study registration until disease recurrence or death, assessed up to 5 years
Other Pre-specified Outcome Measures:
Title
Change in FRalpha expression
Description
Assessed using simple summary statistics (mean and 95% confidence interval.
Time Frame
Baseline up to week 107
Title
Change in the number of FRalpha-specific IL-17-secreting Th cells
Description
Assessed using simple summary statistics (mean and 95% confidence interval.
Time Frame
Baseline up to week 107
Title
Change in the number of FRalpha-specific T cells that secrete IFNgamma, TNFalpha, IL-10, and granzyme B
Description
Assessed using simple summary statistics (mean and 95% confidence interval.
Time Frame
Baseline up to week 107
Title
Changes in peripheral blood immune cell subsets
Description
Assessed using simple summary statistics (mean and 95% confidence interval.
Time Frame
Baseline up to week 107
Title
DTH skin reaction specific for FRalpha.
Description
The percent of each category will be calculated along with a 95% confidence interval.
Time Frame
Up to week 104
Title
Induction of antibodies specific for FRalpha
Description
The percent of each category will be calculated along with a 95% confidence interval.
Time Frame
Up to week 107

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Block
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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