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
4 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2014
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedStudy Start
First participant enrolled
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedOctober 31, 2025
May 1, 2025
7.3 years
April 7, 2014
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 3 weeks
Secondary Outcomes (2)
Overall survival (OS)
Number of days from study registration until death due to any cause, assessed up to 5 years
Time to disease recurrence (TDR)
Number of days from study registration until disease recurrence or death, assessed up to 5 years
Other Outcomes (6)
Change in FRalpha expression
Baseline up to week 107
Change in the number of FRalpha-specific IL-17-secreting Th cells
Baseline up to week 107
Change in the number of FRalpha-specific T cells that secrete IFNgamma, TNFalpha, IL-10, and granzyme B
Baseline up to week 107
- +3 more other outcomes
Study Arms (1)
Treatment (vaccine therapy)
EXPERIMENTALINDUCTION 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.
Interventions
Given ID
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew S. Block, M.D., Ph.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 11, 2014
Study Start
April 14, 2014
Primary Completion
July 27, 2021
Study Completion
July 27, 2021
Last Updated
October 31, 2025
Record last verified: 2025-05