NCT00066729

Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Detailed description

OBJECTIVES: * Determine the safety of NY-ESO-1b peptide vaccine and Montanide® ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer. * Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients. OUTLINE: This is an open-label study. Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide® ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks (week 16) and then every 6-12 weeks for 2 years or until disease progression.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	NY-ESO-1 peptide vaccine	NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51

Timeline

• Start date: 2003-06-23
• Primary completion: 2006-05-09
• Completion: 2013-08-01
• First posted: 2003-08-07
• Last updated: 2023-10-04
• Results posted: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study