NCT00112957

Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Phase II Study of Recombinant Vaccinia-NY-ESO-1 (rV-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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a complete response to standard therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy, cellular and humoral immunity and any correlation with time to failure, and safety.

Detailed description

Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 plaque forming units \[PFU\]) on Day 1, followed by monthly subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) for 6 months (Days 29, 57, 85, 113, 141, and 169) or until observation of treatment-related ≥ grade 3 toxicity or disease progression. Study injections were administered during a 28-week evaluation period. Patients returned to the clinic for follow-up on Day 197 (i.e., 28 days after the last study injection) and every 2 months thereafter for at least 12 months. In patients with measurable disease, tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Patients were monitored continuously for safety for the duration of study participation.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	rV-NY-ESO-1 vaccine	Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1.
BIOLOGICAL	rF-NY-ESO-1 vaccine	Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169.

Timeline

• Start date: 2004-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-06-03
• Last updated: 2023-10-04
• Results posted: 2018-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study