Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI MSKCC-99121 NCI-H00-0060, NCT00006041

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

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)

Expected Enrollment

A total of 18-24 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Paul Sabbatini, MD, Protocol chair		Ph: 212-639-6423; 800-525-2225

Registry Information
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
Trial Start Date		2000-02-21
Registered in ClinicalTrials.gov		NCT00006041
Date Submitted to PDQ		2000-06-06
Information Last Verified		2000-10-01
NCI Grant/Contract Number		CA52477