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

Phase 1
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed ovarian, fallopian tube, or peritoneal
epithelial cancer (any stage at diagnosis) Prior cytoreductive surgery required Refractory
or recurrent after at least one prior regimen of platinum based chemotherapy No evidence
of disease following salvage chemotherapy, defined as: CA125 less than 35 units Negative
physical examination No evidence of disease on CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin, SGOT, and alkaline phosphatase less than 2 times normal
Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: No
other concurrent active invasive malignancy No seafood allergy No positive stool guaiac
(excluding hemorrhoids)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

February 2002

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021