Ovarian Cancer Clinical Trial
Official title:
Vaccination of Patients Who Have Ovarian, Fallopian Tube or Peritoneal Cancer With Glycosylated MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS-21
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.
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.
;
Primary Purpose: Treatment
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