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A Study of FRaDCs for Ovarian Cancer

Primary Purpose

Fallopian Tube Carcinosarcoma, Primary Peritoneal Carcinosarcoma, Recurrent Fallopian Tube Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Computed Tomography
Magnetic Resonance Imaging
Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Pembrolizumab
Pheresis
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Carcinosarcoma

Eligibility Criteria

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

Inclusion Criteria: Age >= 18 years Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha (Kalli, Oberg, Keeney, & et al., 2008). Mixed carcinomas, including carcinosarcomas, with >= 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible Ovarian cancer (OC) recurrence - Platinum sensitivity/resistance Platinum-refractory (defined as recurrence or progression of OC =< 30 days of the last dose of platinum-based chemotherapy) Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy) Platinum-sensitive (defined as recurrence or progression >=181 days after the last dose of platinum-based chemotherapy). NOTE: Patients with platinum-sensitive recurrent OC must have either received at least two prior courses of platinum-based chemotherapy AND/OR have a documented allergy to carboplatin NOTE: Any number of prior therapies or maintenance regimens for OC are allowed At least one of the following: Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND/OR CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Hemoglobin >= 8.5 g/dL (obtained =< 15 days prior to registration) Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 15 days prior to registration) Platelet count >= 75,000/mm^3 (obtained =< 15 days prior to registration) Lymphocytes >= 0.3 x 10^9/L (obtained =< 15 days prior to registration) Monocytes >= 0.25 x 10^9/L (obtained =< 15 days prior to registration) Total bilirubin =< 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =< ULN (obtained =< 15 days prior to registration) Aspartate transaminase (AST) =< 3 x ULN (obtained =< 15 days prior to registration) Creatinine clearance >= 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =< 15 days prior to registration) Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Provide written informed consent Willing to provide mandatory blood and tissue specimens for correlative research Willing to provide archival tissue specimen for correlative research Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study) Willing to undergo a tetanus vaccination (if not performed =< 365 days prior to registration) Willing to have a central access line placed, if needed (as determined during venous access assessment) Exclusion Criteria: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown Pregnant persons Nursing persons Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody Treatment with IV anti-cancer therapy =< 3 weeks prior to registration or with oral anti-cancer therapy =< 1 week prior to registration NOTE: Since treatment will begin no sooner than 4 weeks after registration due to the need for apheresis and manufacturing of the FRalphaDC product, a "wash-out" period of 3 or 1 week(s) prior to registration will cause a gap of at least 7 or 5 weeks between the last anti-cancer treatment and initiation of protocol therapy Grade 2 or higher symptoms attributed to OC OR disease measuring > 5 cm in long axis (non-nodal lesions), or > 5 cm in short axis (nodal lesions) OR disease that, in the judgement of the treating investigator, is likely to become symptomatic in the next 8 weeks (ex. moderate ascites) NOTE: Since patients will not receive therapy for cancer until 3-4 weeks after apheresis-potentially 6-8 weeks after registration-patients with symptomatic OC or an elevated tumor burden may experience significant progression prior starting therapy and should not be treated on this protocol.) 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 Known history of human immunodeficiency virus (HIV) infection NOTE: No HIV testing is required unless mandated by local health authority Uncontrolled intercurrent illness including, but not limited to: Ongoing or active serious infections (e.g., pneumonia, sepsis) requiring systemic therapy Current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids Active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) =< 2 years prior to registration Psychiatric illness/social situations that would limit compliance with study requirements Concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. EXCEPTIONS: For patients with evidence of hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive), patients must have completed at least 4 weeks of hepatitis B virus (HBV) antiviral therapy and the HBV viral load must be undetectable at the time of registration Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment >= 4 weeks prior to registration NOTE: Patients without symptoms or prior history do not require testing prior to registration Other active malignancy either requiring palliative systemic therapy =< 3 years prior to registration, or likely to require treatment in the next 2 years EXCEPTIONS: Patients with non-melanotic skin cancer, papillary thyroid cancer not requiring therapy or carcinoma-in-situ are eligible for this trial. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias NOTE: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone >10 mg/day or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF]-alpha agents) =< 7 days prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study NOTE: Patients who have received acute, low-dose systemic steroids (=< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., =< 48 hours of corticosteroids for a contrast allergy) are eligible for the study NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed History of allogeneic stem cell transplant

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (apheresis, FRalphaDC, pembrolizumab)

Arm Description

Patients undergo apheresis for multi-epitope folate receptor alpha-loaded dendritic cell vaccine manufacturing on study. Patients then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID and pembrolizumab IV on study. Patients also undergo CT and/or MRI as well as blood sample collection throughout the trial. Patients undergo biopsy on study.

Outcomes

Primary Outcome Measures

Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.
Three patients will be enrolled to starting dose (dose level 1) and enrollment will pause until each of the first 3 patients have completed cycle 1 of therapy. If zero or one of first 3 patients develops a dose limiting toxicity (DLT) during cycle 1, 3 more patients will be enrolled to dose level 1. If observe at most 1 DLT in the first 6 patients at dose level 1, it will be considered safe and will continue in phase II of trial. If 2 or more of the first 6 patients develop a DLT during cycle 1 for dose level 1, then enrollment will stop and dose level will be decreased. Additional patients will be enrolled in cohorts of 3 to that decreased dose level. If zero or one DLT in the first 6 patients at dose level -1, it will be considered safe and will continue in phase II of trial. Otherwise, if observe 2 or more DLTs in the first 6 patients of dose level -1, enrollment will stop until the Study Team adjusts the treatment plan with input from the Data Safety Monitoring Board.
Confirm objective response rate (ORR)
Defined as the proportion of patients with a complete response (CR) or partial response (PR). If at least 7 confirmed responses are observed in the first 32 eligible patients (22%), the combination treatment will be considered worthy of further investigation.

Secondary Outcome Measures

Duration of response
Duration of response (DoR) is defined as the time from the first disease assessment showing a complete response (CR) or partial response (PR) until the date of either disease progression or death of any cause.
Progression free survival (PFS)
PFS will be estimated using the Kaplan-Meier method. The date of progression will be the date on which progressive disease is first detected, even if the patient does not immediately come off study.
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method. OS is defined as the time from study entry to death from any cause.
Incidence of adverse events
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0.

Full Information

First Posted
June 9, 2023
Last Updated
September 28, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05920798
Brief Title
A Study of FRaDCs for Ovarian Cancer
Official Title
FRαDCs Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
July 15, 2027 (Anticipated)
Study Completion Date
July 15, 2027 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. 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. To determine whether the combination of FRalphaDCs and pembrolizumab has an acceptable toxicity profile in patients with recurrent ovarian cancer (OC). (Phase I) II. To measure the confirmed objective response rate (ORR) to the combination of FRalphaDCs and pembrolizumab in patients with recurrent OC. (Phase II) SECONDARY OBJECTIVES: I. To estimate the disease control rate (DCR-percentage of patients achieving a complete response, partial response, or stable disease) of the combination of FRalphaDCs and pembrolizumab in patients with recurrent OC. II. To estimate the duration of response (DoR) in patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. III. To estimate the progression-free survival (PFS) of patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. IV. To estimate the overall survival (OS) of patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. 2.25 To characterize the adverse event (AE) profile in patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. CORRELATIVE OBJECTIVES: I. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IL-17-secreting T cells (Th17s) in patients with recurrent OC. II. Characterize the T cell and antibody responses to FRalpha and assess the association between the emergence of immunity and recurrence-free (RFS). III. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IFNgamma-secreting T cells (Th1s) in patients with recurrent OC. IV. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IgG antibodies in patients with recurrent OC. V. To determine whether the combination of FRalphaDCs and pembrolizumab induces changes in the immune microenvironment of ovarian tumors. OUTLINE: Patients undergo apheresis for multi-epitope folate receptor alpha-loaded dendritic cell vaccine manufacturing on study. Patients then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine intradermally (ID) and pembrolizumab intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial. Patients undergo biopsy on study. Patients are followed up at 90 days after last dose, every 3 months until 24 months after registration or until progression of disease, and then every 6 months up to 5 years after registration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Carcinosarcoma, Primary Peritoneal Carcinosarcoma, Recurrent Fallopian Tube Carcinoma, Recurrent Fallopian Tube Clear Cell Adenocarcinoma, Recurrent Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Fallopian Tube High Grade Serous Adenocarcinoma, Recurrent Ovarian Carcinoma, Recurrent Ovarian Carcinosarcoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma, Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Primary Peritoneal Carcinoma, Recurrent Primary Peritoneal Clear Cell Adenocarcinoma, Recurrent Primary Peritoneal Endometrioid Adenocarcinoma, Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (apheresis, FRalphaDC, pembrolizumab)
Arm Type
Experimental
Arm Description
Patients undergo apheresis for multi-epitope folate receptor alpha-loaded dendritic cell vaccine manufacturing on study. Patients then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID and pembrolizumab IV on study. Patients also undergo CT and/or MRI as well as blood sample collection throughout the trial. Patients undergo biopsy on study.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
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
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab, MK-3475, SCH 900475
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Pheresis
Other Intervention Name(s)
Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis, Hemapheresis
Intervention Description
Undergo apheresis
Primary Outcome Measure Information:
Title
Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.
Description
Three patients will be enrolled to starting dose (dose level 1) and enrollment will pause until each of the first 3 patients have completed cycle 1 of therapy. If zero or one of first 3 patients develops a dose limiting toxicity (DLT) during cycle 1, 3 more patients will be enrolled to dose level 1. If observe at most 1 DLT in the first 6 patients at dose level 1, it will be considered safe and will continue in phase II of trial. If 2 or more of the first 6 patients develop a DLT during cycle 1 for dose level 1, then enrollment will stop and dose level will be decreased. Additional patients will be enrolled in cohorts of 3 to that decreased dose level. If zero or one DLT in the first 6 patients at dose level -1, it will be considered safe and will continue in phase II of trial. Otherwise, if observe 2 or more DLTs in the first 6 patients of dose level -1, enrollment will stop until the Study Team adjusts the treatment plan with input from the Data Safety Monitoring Board.
Time Frame
Up to 21 days
Title
Confirm objective response rate (ORR)
Description
Defined as the proportion of patients with a complete response (CR) or partial response (PR). If at least 7 confirmed responses are observed in the first 32 eligible patients (22%), the combination treatment will be considered worthy of further investigation.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Duration of response
Description
Duration of response (DoR) is defined as the time from the first disease assessment showing a complete response (CR) or partial response (PR) until the date of either disease progression or death of any cause.
Time Frame
Up to 5 years
Title
Progression free survival (PFS)
Description
PFS will be estimated using the Kaplan-Meier method. The date of progression will be the date on which progressive disease is first detected, even if the patient does not immediately come off study.
Time Frame
Up to 5 years
Title
Overall survival (OS)
Description
OS will be estimated using the Kaplan-Meier method. OS is defined as the time from study entry to death from any cause.
Time Frame
Up to 5 years
Title
Incidence of adverse events
Description
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha (Kalli, Oberg, Keeney, & et al., 2008). Mixed carcinomas, including carcinosarcomas, with >= 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible Ovarian cancer (OC) recurrence - Platinum sensitivity/resistance Platinum-refractory (defined as recurrence or progression of OC =< 30 days of the last dose of platinum-based chemotherapy) Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy) Platinum-sensitive (defined as recurrence or progression >=181 days after the last dose of platinum-based chemotherapy). NOTE: Patients with platinum-sensitive recurrent OC must have either received at least two prior courses of platinum-based chemotherapy AND/OR have a documented allergy to carboplatin NOTE: Any number of prior therapies or maintenance regimens for OC are allowed At least one of the following: Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND/OR CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Hemoglobin >= 8.5 g/dL (obtained =< 15 days prior to registration) Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 15 days prior to registration) Platelet count >= 75,000/mm^3 (obtained =< 15 days prior to registration) Lymphocytes >= 0.3 x 10^9/L (obtained =< 15 days prior to registration) Monocytes >= 0.25 x 10^9/L (obtained =< 15 days prior to registration) Total bilirubin =< 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =< ULN (obtained =< 15 days prior to registration) Aspartate transaminase (AST) =< 3 x ULN (obtained =< 15 days prior to registration) Creatinine clearance >= 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =< 15 days prior to registration) Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Provide written informed consent Willing to provide mandatory blood and tissue specimens for correlative research Willing to provide archival tissue specimen for correlative research Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study) Willing to undergo a tetanus vaccination (if not performed =< 365 days prior to registration) Willing to have a central access line placed, if needed (as determined during venous access assessment) Exclusion Criteria: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown Pregnant persons Nursing persons Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody Treatment with IV anti-cancer therapy =< 3 weeks prior to registration or with oral anti-cancer therapy =< 1 week prior to registration NOTE: Since treatment will begin no sooner than 4 weeks after registration due to the need for apheresis and manufacturing of the FRalphaDC product, a "wash-out" period of 3 or 1 week(s) prior to registration will cause a gap of at least 7 or 5 weeks between the last anti-cancer treatment and initiation of protocol therapy Grade 2 or higher symptoms attributed to OC OR disease measuring > 5 cm in long axis (non-nodal lesions), or > 5 cm in short axis (nodal lesions) OR disease that, in the judgement of the treating investigator, is likely to become symptomatic in the next 8 weeks (ex. moderate ascites) NOTE: Since patients will not receive therapy for cancer until 3-4 weeks after apheresis-potentially 6-8 weeks after registration-patients with symptomatic OC or an elevated tumor burden may experience significant progression prior starting therapy and should not be treated on this protocol.) 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 Known history of human immunodeficiency virus (HIV) infection NOTE: No HIV testing is required unless mandated by local health authority Uncontrolled intercurrent illness including, but not limited to: Ongoing or active serious infections (e.g., pneumonia, sepsis) requiring systemic therapy Current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids Active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) =< 2 years prior to registration Psychiatric illness/social situations that would limit compliance with study requirements Concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. EXCEPTIONS: For patients with evidence of hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive), patients must have completed at least 4 weeks of hepatitis B virus (HBV) antiviral therapy and the HBV viral load must be undetectable at the time of registration Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment >= 4 weeks prior to registration NOTE: Patients without symptoms or prior history do not require testing prior to registration Other active malignancy either requiring palliative systemic therapy =< 3 years prior to registration, or likely to require treatment in the next 2 years EXCEPTIONS: Patients with non-melanotic skin cancer, papillary thyroid cancer not requiring therapy or carcinoma-in-situ are eligible for this trial. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias NOTE: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone >10 mg/day or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF]-alpha agents) =< 7 days prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study NOTE: Patients who have received acute, low-dose systemic steroids (=< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., =< 48 hours of corticosteroids for a contrast allergy) are eligible for the study NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed History of allogeneic stem cell transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew S. Block, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Matthew S. Block, M.D., Ph.D.

12. IPD Sharing Statement

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

Learn more about this trial

A Study of FRaDCs for Ovarian Cancer

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