NCT00006041

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

Vaccination of Patients Who Have Ovarian, Fallopian Tube or Peritoneal Cancer With Glycosylated MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS-21

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

Detailed description

OBJECTIVES: I. Determine the safety of immunization with glycosylated MUC-1-KLH vaccine plus adjuvant QS21 in patients with ovarian, fallopian tube, or peritoneal epithelial cancer. II. Determine the dose of this treatment regimen for optimal antibody response in these patients. III. Determine the effect of immunization with this treatment regimen on the T-cell response in these patients. OUTLINE: This is a dose escalation study of glycosylated MUC-1-KLH vaccine. Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3, 7, and 19. Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined. Patients are followed at 2 and 12 weeks, and then every 3 months thereafter as long as detectable immunity against MUC-1 persists. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	MUC1-KLH conjugate vaccine
BIOLOGICAL	MUC1-KLH vaccine/QS21
BIOLOGICAL	QS21

Timeline

• Start date: 2000-02-01
• Primary completion: 2002-02-01
• Completion: 2002-02-01
• First posted: 2004-06-28
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States