Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial
Recruiting
Phase 2
Interventional Study
Advanced Fallopian Tube Carcinoma
Advanced Fallopian Tube High Grade Serous Adenocarcinoma
Advanced Ovarian Carcinoma
Advanced Ovarian Carcinosarcoma
Advanced Ovarian Clear Cell Adenocarcinoma
Advanced Ovarian Endometrioid Adenocarcinoma
Advanced Ovarian High Grade Serous Adenocarcinoma
Advanced Primary Peritoneal Carcinoma
Advanced Primary Peritoneal High Grade Serous Adenocarcinoma
Fallopian Tube Carcinosarcoma
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
FIGO Stage III Ovarian Cancer 2014
FIGO Stage IV Ovarian Cancer 2014
Ovarian Mixed Cell Adenocarcinoma
Primary Peritoneal Carcinosarcoma
Primary Peritoneal Clear Cell Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- Mayo Clinic · Other
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About This Trial
This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Histological confirmation of Federation of Gynecology and Obstetrics (FIGO) stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. NOTE: Histologic confirmation of the primary tumor is required. Eligible histotypes include high…
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