Phase II Study of Recombinant Vaccinia-NY-ESO-1 (rF-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
- Determine the remission rate in patients with NY-ESO-1 or LAGE-1 expressing stage II-IV
ovarian epithelial, fallopian tube, or primary peritoneal cancer who are still in
complete clinical remission 12 months after initial documentation of remission treated
with vaccine therapy comprising vaccinia-NY-ESO-1 vaccine and fowlpox-NY-ESO-1 vaccine.
- Determine the NY-ESO-1 specific cellular and humoral immunity, by evaluating NY-ESO-1
specific antibody and CD8+ T cells induced by this regimen, in these patients.
- Correlate time to treatment failure with vaccine-induced NY-ESO-1 antigen specific
cellular or humoral immunity in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive vaccinia-NY-ESO-1 vaccine intradermally on day 1 and fowlpox-NY-ESO-1
vaccine subcutaneously on days 29, 57, 85, 113, 141, and 169 in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 2 months for 1
year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 14-36
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Remission rate at 1 month, every 2 months for 1 year, and then annually post-treatment
every 2 months for 1 year, then annually
Adekunle O. Odunsi, MD, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|