Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

Stopped early · Phase 1

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

Vaccines may make the body build an immune response to kill tumor cells. This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.

Key facts

Study ID

NCT00071942

Run by

National Cancer Institute (NCI)

People needed

22

Starts

2003-10-01

Last updated by the study team

2013-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a histologically confirmed diagnosis of metastatic carcinoma of the breast; measurable disease is not required; subjects who are NED are eligible; subjects must have had at least one prior regimen of chemotherapy, immunotherapy, or hormonal therapy prior to entering this study; subjects may have received any number of prior therapies for metastatic disease
• Subjects must have an ECOG performance status of 0-1
• WBC > 2000/mm\^3
• Platelet count > 100,000/mm\^3
• Serum creatinine =< 2.0 mg/dl
• Serum bilirubin =< 1.5 mg/dl
• SGPT < 3 times the upper limit of normal
• >= 4 weeks since chemotherapy (>= 6 weeks for nitrosoureas or mitomycin C), hormonal therapy or radiation therapy; subjects must have recovered from all acute toxicity associated with the prior regimen; subjects receiving concurrent hormonal treatment or local radiation are not eligible
• Subjects must be HLA typed if not already previously done (5/10 subjects at the MTD dose level must be HLA A2 positive)
• Subjects must not have clinical evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); subjects must be HIV antibody negative; this treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity
• Subjects must not have undergone splenectomy
• The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least three weeks after vaccination, their close household contacts: persons with active or a history of extensive eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection; close household contacts are those who share housing or have close physical contact; determination of the severity of these conditions will be made by the investigator or co-investigator
• Subjects must not have any other serious medical condition that in the opinion of the investigator is incompatible with the protocol; subjects with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days
• Subjects must have had prior vaccinia (smallpox) exposure, determined by subject history, medical documentation, or scar characteristic of vaccinia exposure; there must be no history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination
• Tumor tissue positive for staining with MAbs DF3 and/or DF3-P or elevated serum CA15-3 (also known as CA27-29); note: this can be done on stored slides, but subject will be responsible for costs if not covered by insurance
• Subjects must not have a history of seizures, encephalitis or multiple sclerosis
• Subjects must not be allergic to eggs
• Women of child-bearing potential must agree to use highly effective contraception or abstinence prior to study entry and for at least 4 weeks after the last vaccination; women who are breast-feeding are not eligible for this study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Signed informed consent
• Participants who have been previously treated with vaccinia vectors or MUC1 such as those on protocol T98-0057 (DFPCC # 97-050) are not eligible for this study

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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