Evaluation of the Immunogenicity of Vaccination With Synthetic Peptides in Adjuvant in Patients With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- Determine the immunogenicity of vaccine therapy comprising synthetic ovarian
cancer-associated peptides administered with a synthetic tetanus toxoid helper peptide
emulsified in Montanide ISA-51 before or after paclitaxel and carboplatin in patients
with stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube
cancer undergoing optimal cytoreductive surgery.
OUTLINE: This is an open-label study. Patients are assigned to 1 of 2 treatment groups.
- Group 1:
- Neoadjuvant chemotherapy:Patients receive paclitaxel IV over 3 hours and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to
4 courses in the absence of disease progression or unacceptable toxicity. Patients
then proceed to surgical debulking.
- Surgical debulking: Patients undergo primary optimal cytoreductive surgery.
- Vaccine therapy: Within 14 days after surgery, patients receive vaccine therapy
comprising synthetic ovarian cancer-associated peptides, MAGE-A1:161-169,
FBP:1901-199, Her-2/neu:369-377, MAGE-A1:96-104, and Her-2/neu:754-762, and
tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and
subcutaneously on days 1, 8, and 15. Treatment repeats every 14 weeks for 2
- Adjuvant chemotherapy: Patients receive 4 courses of paclitaxel and carboplatin as
in neoadjuvant chemotherapy after completion of course 1 of vaccine therapy.
- Group 2:
- Surgical debulking: Patients undergo up-front optimal cytoreductive surgery.
Patients with non-optimal primary debulking may undergo interval debulking surgery
within 6 weeks after completing course 4 of adjuvant chemotherapy. If interval
debulking surgery is performed, tumor and/or lymph node tissue is collected.
- Vaccine therapy: Patients receive 2 courses of vaccine therapy as in group 1.
- Adjuvant chemotherapy: Patients receive paclitaxel and carboplatin as in group 1,
neoadjuvant chemotherapy. Treatment repeats every 21 days for up to 8 courses.
Patients undergo periodic blood and tumor tissue collection during study for correlative
After completion of study treatment, patients with progressive disease are followed at 30
days and then every six months thereafter. All other patients are followed every 3 months
for 36 months until disease progression or until another therapy is initiated, and then
every six months thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Cytotoxic T-cell response to vaccine therapy comprising 5 synthetic ovarian cancer-associated peptides, as assessed using peripheral blood during course 1
Amir A. Jazaeri, MD
University of Virginia
United States: Food and Drug Administration
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|