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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00713 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 13-004398 | Other Identifier | Mayo Clinic Institutional Review Board | |
| P50CA136393 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (vaccine therapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FRalpha expression | 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 | Assessed using simple summary statistics (mean and 95% confidence interval. |
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:
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:
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:
Use of a systemic steroid (> 5 mg prednisone daily or equivalent) =< 4 weeks prior to registration
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| Name | Affiliation | Role |
|---|---|---|
| Matthew S. Block, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine |
| Biological |
Given ID |
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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 |
| Baseline up to week 107 |
| Change in the number of FRalpha-specific T cells that secrete IFNgamma, TNFalpha, IL-10, and granzyme B | Assessed using simple summary statistics (mean and 95% confidence interval. | Baseline up to week 107 |
| Changes in peripheral blood immune cell subsets | Assessed using simple summary statistics (mean and 95% confidence interval. | Baseline up to week 107 |
| DTH skin reaction specific for FRalpha. | The percent of each category will be calculated along with a 95% confidence interval. | Up to week 104 |
| Induction of antibodies specific for FRalpha | The percent of each category will be calculated along with a 95% confidence interval. | Up to week 107 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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