Brief Title
Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
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
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
MUC1-KLH conjugate vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
February 2000
Completion Date
February 2002
Primary Completion Date
February 2002
Eligibility 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
specified
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006041
Organization ID
99-121
Secondary IDs
CDR0000068056
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013