Brief Title
Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy
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
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary Outcome
Overall survival (OS)
Condition
Fallopian Tube Clear Cell Adenocarcinoma
Intervention
Laboratory Biomarker Analysis
Study Arms / Comparison Groups
Treatment (vaccine therapy)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
19
Start Date
April 14, 2014
Completion Date
December 15, 2023
Primary Completion Date
August 18, 2017
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Matthew Block, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02111941
Organization ID
MC1361
Secondary IDs
NCI-2014-00713
Responsible Party
Sponsor
Study Sponsor
Mayo Clinic
Study Sponsor
Matthew Block, Principal Investigator, Mayo Clinic
Verification Date
October 2022