Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 22
Summary
- Conditions
- Ovarian Seromucinous Carcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Tumor
- Fallopian Tube Mucinous Neoplasm
- Stage IIIC Primary Peritoneal Cancer
- Undifferentiated Ovarian Carcinoma
- Fallopian Tube Serous Neoplasm
- Fallopian Tube Transitional Cell Carcinoma
- Ovarian Clear Cell Cystadenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Recurrent Ovarian Carcinoma
- Stage IIIC Ovarian Cancer
- Ovarian Mucinous Cystadenocarcinoma
- Stage IV Ovarian Cancer
- Ovarian Serous Cystadenocarcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Stage IV Primary Peritoneal Cancer
- Undifferentiated Fallopian Tube Carcinoma
- Stage IV Fallopian Tube Cancer
- Primary Peritoneal Serous Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Stage IIIC Fallopian Tube Cancer
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 ove...
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.
Tracking Information
- NCT #
- NCT02111941
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Matthew Block Mayo Clinic
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