RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have breast cancer.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage IIIB breast cancer stage IIIA breast cancer stage IV breast cancer recurrent breast cancer stage II breast cancer	Drug: keyhole limpet hemocyanin  Drug: MUC-1 antigen  Drug: QS21	Phase II

Further Study Details: 

OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with high risk breast cancer expressing MUC-1.

PROTOCOL OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1(106) or MUC-1(33) with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, and 19 for a total of 5 vaccinations. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosed breast cancer at high risk for disease recurrence with one of the following requirements: Disease free stage IV breast cancer following eradication of disease by surgery, radiotherapy, or chemotherapy; Stage I, II, or III breast cancer remaining clinically free of identifiable disease following adjuvant chemotherapy with 2 consecutively rising CA15.3 (BR2729) or CEA levels at least 2 weeks apart; Elevation of marker levels not needed for stage III disease if adjuvant therapy completed within past 2 years CEA increase at least 1.5 times upper chronic value in patients with significant smoking history and chronic CEA elevation less than 15; Recurrence in the ipsilateral axilla following lumpectomy/axillary dissection or modified radical mastectomy; Recurrence in the ipsilateral breast following lumpectomy/axillary dissection
• Stage II disease with at least 4 positive axillary lymph nodes and adjuvant therapy completed within past 2 years; Stable stage IV disease on hormonal therapy
• Colonoscopy required for isolated CEA elevation
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: At least 6 weeks since prior immunotherapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy; No concurrent radiotherapy
• Surgery: See Disease Characteristics; At least 4 weeks since prior surgery

--Patient Characteristics--

• Age: 18 and over
• Menopausal status: Not specified
• Performance status: Karnofsky 90-100%
• Life expectancy: Not specified
• Hematopoietic: Lymphocyte count at least 500/mm3; WBC at least 3,000/mm3
• Hepatic: Alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 1.5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN
• Cardiovascular: No New York Heart Association class III or IV heart disease
• Other: No immunodeficiency or autoimmune disease; No seafood allergies; No other active malignancies except basal cell or squamous cell skin cancer; Not pregnant; Negative pregnancy test; Fertile patients must use effective barrier contraception

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

Study chairs or principal investigators

Teresa Ann Gilewski,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067394; MSKCC-99023; NCI-H99-0043
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004156
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08