A Pilot Study of the Safety and Immunogenicity of Folate Receptor Alpha Peptide-Loaded Dendritic Cell Vaccination in Patients with Advanced Stage Epithelial Ovarian Cancer

Who is this study for? Patients with Ovarian, Fallopian Tube Cancer
What treatments are being studied? Laboratory Biomarker Analysis+Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Status: Active_not_recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic
Rochester
Time Frame
Start Date: 2014-04-14
Completion Date: 2025-06-30
Participants
Target number of participants: 19
Treatments
Experimental: Treatment (vaccine therapy)
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.
Authors
Martin J. Cannon, Matthew Block
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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