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

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Procedure: biological response modifier therapy  Procedure: vaccine therapy  Vaccine: recombinant viral vaccine  Drug: recombinant vaccinia DF3/MUC1 vaccine	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients.

PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven metastatic adenocarcinoma of the breast; Tumor tissue positive for staining with DF3 (CA27-29) and/or DF3-P OR Elevated serum CA15-3 (CA27-29)
• May have received no prior treatment or any number of prior regimens for metastatic disease
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: Prior vaccinia virus exposure required; No other concurrent biologic therapy
• Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Endocrine therapy: At least 3 weeks since prior hormonal therapy; No concurrent steroids or hormonal therapy
• Radiotherapy: At least 3 weeks since prior radiotherapy; No concurrent radiotherapy
• Surgery: No prior splenectomy
• Other: At least 3 days since prior antibiotics

--Patient Characteristics--

• Age: 18 and over
• Menopausal status: Not specified
• Performance status: ECOG 0 or 1
• Life expectancy: Not specified
• Hematopoietic: WBC greater than 2,000/mm3; Platelet count greater than 100,000/mm3
• Hepatic: Bilirubin less than 2.0 mg/dL; SGPT less than 4 times upper limit of normal
• Renal: Creatinine less than 2.0 mg/dL
• Immunologic: At least normal delayed type hypersensitivity; At least normal CD4:CD8 ratio (greater than 1); At least normal lymphocyte proliferation to concanavalin A; At least normal immunoglobulin levels; No evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); If no antivaccinia antibodies, then must have physician certification of prior vaccinia immunization OR patient recollection and appropriate vaccination site scar
• Other: HIV negative; No prior or concurrent extensive skin disorders (e.g., eczema, extensive psoriasis, burns, impetigo, disseminated zoster); No other serious medical condition that would preclude study participation; No active infection requiring antibiotics; Must be able to avoid close contact with children under 3 years old, pregnant women, individuals with eczema or other skin conditions, and immunosuppressed people for 2 weeks after each vaccination; No seizures, encephalitis, or multiple sclerosis; No allergy to eggs; Not pregnant or nursing; Fertile patients must use effective contraception

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Donald W. Kufe,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000066886; DFCI-97050; NCI-T98-0057
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003761
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08