Finding studies
Finding studies
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Clinical Trials Referral Office
CONTACT
Lead
Mayo Clinic
PRIMARY OBJECTIVE: I. Compare recurrence-free survival (RFS) in advanced ovarian carcinoma (OC) patients vaccinated with multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRαDCs) (active vaccine) versus placebo. SECONDARY OBJECTIVES: I. Compare overall survival (OS) in advanced OC patients vaccinated with FRαDCs versus placebo. II. Compare the adverse event (AE) profile of FRαDCs with that of placebo. CORRELATIVE RESEARCH OBJECTIVES: I. Assess association of pre-existing immune microenvironment with RFS. II. Characterize the T cell and antibody responses to FRα and assess the association between the emergence of immunity and RFS. III. Assess for epitope spreading and evaluate the association between epitope spreading and RFS. IV. Compare archival tissue from surgery with post-recurrence biopsy tissue in those patients who develop recurrence to assess for common immune evasion mechanisms. V. Evaluate differences in ribonucleic acid (RNA) expression of FRαDCs and its association with RFS. OUTLINE: Patients are randomized to 1 of 2 arms. Randomization is 2:1, vaccine to placebo. ARM I: Patients may receive tetanus and diphtheria vaccine (Td) or tetanus-diphtheria-accellular pertussis vaccine (Tdap) intramuscularly (IM) prior to undergoing leukapheresis. Patients receive FRalphaDCs intradermally (ID) on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study.f ARM II: Patients may receive Td or Tdap IM prior to undergoing leukapheresis. Patients receive placebo ID on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy prior to apheresis and optionally at end of treatment, and blood sample collection, CT and/or MRI throughout the study. After completion of study treatment, patients are followed up every 3 months for up to month 36 then every 3 months until progression followed by every 6 months for up to year 8.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
