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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02111941
Other study ID # MC1361
Secondary ID NCI-2014-0071313
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date April 14, 2014
Est. completion date June 30, 2025

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 19
Est. completion date June 30, 2025
Est. primary completion date July 27, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Endometrioid
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Transitional Cell
  • Cystadenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Tumor
  • Fallopian Tube Mucinous Neoplasm
  • Fallopian Tube Neoplasms
  • Fallopian Tube Serous Neoplasm
  • Fallopian Tube Transitional Cell Carcinoma
  • Neoplasms
  • Neoplasms, Cystic, Mucinous, and Serous
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Neoplasms
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Peritoneal Neoplasms
  • Primary Peritoneal Serous Adenocarcinoma
  • Recurrence
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal 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
  • Undifferentiated Fallopian Tube Carcinoma
  • Undifferentiated Ovarian Carcinoma

Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Biological:
Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Given ID

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in FRalpha expression Assessed using simple summary statistics (mean and 95% confidence interval. Baseline up to week 107
Other Change in the number of FRalpha-specific IL-17-secreting Th cells Assessed using simple summary statistics (mean and 95% confidence interval. Baseline up to week 107
Other 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
Other Changes in peripheral blood immune cell subsets Assessed using simple summary statistics (mean and 95% confidence interval. Baseline up to week 107
Other DTH skin reaction specific for FRalpha. The percent of each category will be calculated along with a 95% confidence interval. Up to week 104
Other Induction of antibodies specific for FRalpha The percent of each category will be calculated along with a 95% confidence interval. Up to week 107
Primary 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 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
Secondary Time to disease recurrence (TDR) 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
See also
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Completed NCT00301756 - Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors Phase 2
Completed NCT00066456 - Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00045682 - CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Phase 2
Active, not recruiting NCT03353831 - Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer Phase 3
Active, not recruiting NCT04781088 - Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
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Active, not recruiting NCT03325634 - Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer Phase 1
Completed NCT01039207 - Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Phase 2
Withdrawn NCT00551265 - Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy N/A
Completed NCT00093626 - Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer Phase 2
Terminated NCT02569957 - Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 2
Recruiting NCT04469764 - Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Phase 2
Active, not recruiting NCT01081262 - Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer Phase 3
Active, not recruiting NCT04019288 - AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1/Phase 2
Completed NCT01459380 - Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Phase 1
Terminated NCT03924245 - Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers Phase 1

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