Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the toxicity of vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine in patients with metastatic breast cancer.

• Determine the maximum tolerated dose of this regimen in these patients.

• Determine the toxicity of this regimen when administered with sargramostim (GM-CSF) in these patients.

Secondary

• Determine the host immune reactivity in patients treated with this regimen with or without GM-CSF.

• Determine the antitumor activity in patients treated with this regimen with or without GM-CSF.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients (including 5 HLA-A2-positive patients) receive vaccination as above at the MTD and sargramostim (GM-CSF) subcutaneously on days 1-4 and 29-32.

Patients are followed at 4 weeks, monthly until disease progression, and then annually for up to 15 years.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study within 18-24 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast cancer

• Meets 1 of the following criteria:

• Tumor tissue stains positive with monoclonal antibodies DF3 and/or DF3-P

• Elevated CA 15-3

• Received at least 1 prior regimen of chemotherapy, immunotherapy, or hormonal therapy

• HLA status known

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 2,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• SGPT less than 3 times upper limit of normal

Renal

• Creatinine no greater 2.0 mg/dL

Immunologic

• No active or prior extensive eczema or other eczematoid skin disorders

• No active, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open wounds or rashes)

• No clinical evidence of altered immune responsiveness

• No immunodeficiency or immunosuppression by disease or therapy

• No autoimmune syndromes (e.g., scleroderma or systemic lupus erythematosus)

• No prior allergic or untoward reaction to vaccinia (smallpox) vaccination

• No allergy to eggs

• No active infection requiring antibiotics

• HIV negative

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 4 weeks after study participation

• No history of seizures, encephalitis, or multiple sclerosis

• Must be able to avoid close household contact with any of the following individuals for at least 3 weeks after study vaccination:

• Persons with active or prior extensive eczema or other eczematoid skin disorders

• Persons with acute, chronic, or exfoliative skin disorders

• Pregnant or nursing women

• Children under age 5

• Immunodeficient or immunosuppressed persons (by disease or therapy, including HIV infection)

• No other concurrent serious medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• Prior vaccinia (smallpox) exposure required

• At least 21 days since prior flu vaccination

• No prior vaccinia vectors or MUC1

• No other concurrent anticancer biologic therapy (e.g., interferon or interleukin)

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

• At least 4 weeks since prior hormonal therapy

• No concurrent hormonal treatment

• No concurrent steroid therapy

• Steroid creams or inhalers allowed

• No concurrent dexamethasone or other steroids for antiemetic purposes

Radiotherapy

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• No prior splenectomy

Other

• Recovered from all prior therapy

• At least 3 days since prior antibiotics for active infection

Trial Contact Information

Trial Lead Organizations/Sponsors

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Joseph Paul Eder

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00071942
Information obtained from ClinicalTrials.gov on December 14, 2011

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