- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02111941
Vaccine Therapy for Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
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 Overview
Status
Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Ovarian Clear Cell Cystadenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Seromucinous Carcinoma
- Ovarian Serous Cystadenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Ovarian Transitional Cell Carcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Ovarian Mucinous Cystadenocarcinoma
- Undifferentiated Ovarian 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
- Fallopian Tube Endometrioid Tumor
- Undifferentiated Fallopian Tube Carcinoma
- Fallopian Tube Mucinous Neoplasm
- Fallopian Tube Serous Neoplasm
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew S. Block, M.D., Ph.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Endometrial Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms
- Carcinoma
- Recurrence
- Adenocarcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Cystadenocarcinoma, Serous
- Carcinoma, Endometrioid
- Cystadenocarcinoma
- Adenocarcinoma, Clear Cell
- Carcinoma, Transitional Cell
- Cystadenocarcinoma, Mucinous
- Neoplasms, Cystic, Mucinous, and Serous
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- MC1361 (Mayo Clinic)
- NCI-2014-00713 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 13-004398 (Other Identifier: Mayo Clinic Institutional Review Board)
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
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingOvarian Seromucinous Carcinoma | Recurrent Ovarian High Grade Serous Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Fallopian Tube Mucinous Adenocarcinoma | Recurrent Fallopian Tube Clear Cell Adenocarcinoma | Recurrent Fallopian Tube Endometrioid Adenocarcinoma | Recurrent... and other conditionsUnited States, Puerto Rico
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
Roswell Park Cancer InstituteCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Tumor | Fallopian Tube Endometrioid Tumor | Ovarian Endometrioid Tumor | Fallopian Tube Mucinous Neoplasm | Fallopian Tube Serous Neoplasm | Ovarian Serous Tumor | Ovarian Mucinous...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Seromucinous Carcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Ovarian High Grade Serous Adenocarcinoma | Fallopian... and other conditionsUnited States, Puerto Rico
-
National Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell AdenocarcinomaUnited States
-
M.D. Anderson Cancer CenterAstraZeneca; Aravive Biologics IncActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
Roswell Park Cancer InstituteActive, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Refractory Ovarian... and other conditionsUnited States
Clinical Trials on Laboratory Biomarker Analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized OsteosarcomaUnited States