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A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adnocarcinoma of the Breast


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adnocarcinoma of the Breast


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Donald W. Kufe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066886

NCT ID:

NCT00003761

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms
  • Vaccinia

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Boston Medical CenterBoston, Massachusetts  02118
Brigham and Women's HospitalBoston, Massachusetts  02115