This trial is active, not recruiting.

Condition breast cancer
Treatment recombinant vaccinia df3/muc1 vaccine
Phase phase 1
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date February 1999
Trial size 28 participants
Trial identifier NCT00003761, CDR0000066886, DFCI-97050, NCI-T98-0057


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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 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 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

Additional Information

Official title A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adnocarcinoma of the Breast
Description 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).