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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
This study has been completed.
First Received: November 4, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00071942
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: recombinant vaccinia-MUC-1 vaccine
Biological: recombinant vaccinia-TRICOM vaccine
Biological: sargramostim
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I Trial of an Admixture of Recombinant Vaccinia Virus That Express DF3/MUC1 and rV-TRICOM (B7.ICAM-1, and LFA-3) in Patients With Metastatic Adenocarcinoma of the Breast

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 22
Study Start Date: October 2003
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071942

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Joseph Paul Eder, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000335472, DFCI-02310, NCI-5747
Study First Received: November 4, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00071942     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
male breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010