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Vaccine Therapy Before and After Dose-Intensive Induction Chemotherapy Plus Immune-Depleting Chemotherapy in Treating Patients With Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: January 27, 2003   Last Updated: July 7, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053170
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, doxorubicin and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects, best way to give, and best dose of giving vaccine therapy with dose-intensive induction chemotherapy and immune-depleting chemotherapy and to see how well it works in treating patients with newly-diagnosed metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine
Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine
Biological: sargramostim
Biological: therapeutic autologous lymphocytes
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: fludarabine phosphate
Drug: paclitaxel
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Multicenter Phase I-II Study of Tumor Vaccine Following Chemotherapy in Patients With Metastatic Breast Cancer Untreated With Chemo/Radiation in The Previous 18 Months: Vaccine-Induced Bias Of T-Cell Repertoire Reconstitution After T-Cell Re-Infusion

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-free survival as measured by clinical evaluation and tumor measurements by imaging every 3 months for 3 years and then annually [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: November 2002
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic infiltrating carcinoma of the breast
  • Meets one of the following criteria for newly diagnosed disease:

    • Newly diagnosed with metastatic breast cancer

      • No prior chemotherapy for metastatic disease
    • Known to have breast cancer

      • More than 18 months since prior adjuvant chemotherapy or radiotherapy for nonmetastatic or metastatic disease
  • CEA > 5 OR positive by standard immunohistochemistry

    • Positivity defined as more than 30% of cells staining
  • Measurable or evaluable disease or no evidence of disease (postsurgery)
  • No brain metastases
  • Hormone receptor status:

    • Positive or negative

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status

  • Karnofsky 70-100% OR
  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 90,000/mm^3
  • No history of abnormal bleeding tendency

Hepatic

  • Bilirubin < 1.5 mg/dL* (except in patients with Gilbert's disease)
  • AST and ALT < 3 times upper limit of normal*
  • Hepatitis B and C negative NOTE: *Except if due to tumor involvement of the liver prior to induction therapy

Renal

  • Urinalysis normal

    • If proteinuria is present, must be < 1 g by 24-hour urine collection
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • Ejection fraction normal by MUGA or 2D echocardiogram

    • If ejection fraction is between 35% and 45%, increase of ejection fraction with stress must be estimated at 10% or more
  • No clinically significant cardiomyopathy requiring treatment
  • None of the following:

    • Cardiomyopathy or symptomatic congestive heart failure
    • Symptomatic arrhythmia that is not controlled by medication
    • Unstable coronary artery disease (i.e., unstable angina that require active intervention)
    • Recent infarction or cerebrovascular accident within the past 6 months

Pulmonary

  • Corrected DLCO > 50%

Immunologic

  • No prior or active eczema or other eczematoid skin disorders
  • No predisposition to repeated infections
  • No allergy to eggs or egg products
  • No history of allergy or complications with prior vaccinia vaccination
  • No autoimmune disease, including any of the following:

    • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
    • Rheumatoid arthritis
    • Systemic lupus erythematosus
    • Sjögren's syndrome
    • Scleroderma
    • Systemic sclerosis
    • Myasthenia gravis
    • Multiple sclerosis
    • Goodpasture syndrome
    • Addison's disease
    • Hashimoto's thyroiditis
    • Active Graves' disease
  • No abnormality of any of the following tests:

    • Antinuclear antibody
    • Anti-DNA
    • T3, T4, and thyroid-stimulating hormone* NOTE: *Patients with endocrine disease that is controlled by replacement therapy including diabetes, thyroid and adrenal disease or vitiligo are eligible
  • No immunodeficiency or immunosuppression by disease or therapy
  • HIV negative

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study therapy
  • No active inflammatory bowel disease
  • No acute, chronic, or exfoliative skin conditions, including any of the following:

    • Atopic dermatitis
    • Burns
    • Impetigo
    • Varicella zoster
    • Severe acne
    • Other open wounds or rashes
  • No history of seizures
  • No history of encephalitis
  • No other active malignancy except treated skin cancer or carcinoma in situ
  • No unacceptable medical or psychiatric risk
  • No urgent or emergent clinical situation that would preclude study participation
  • Must be able to avoid close household contact for at least 2 weeks after vaccination with the following individuals:

    • Pregnant or nursing women
    • Children under 3 years of age
    • Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV infection)
    • Individuals with the following conditions:

      • Prior or active eczema or eczematoid skin disorders
      • Other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Prior hormonal therapy for stage IV disease allowed

    • Disease progression on hormonal therapy alone allowed
  • No concurrent chronic corticosteroids

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  • No prior splenectomy

Other

  • No concurrent chronic immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053170

Locations
United States, Maryland
NCI - Center for Cancer Research Recruiting
Bethesda, Maryland, United States, 20892
Contact: Clinical Trials Office - NCI - Center for Cancer Research     888-624-1937        
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
Sponsors and Collaborators
Investigators
Study Chair: Claude Sportes, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: NCI - Center for Cancer Research ( Claude Sportes )
Study ID Numbers: CDR0000269292, NCI-03-C-0040, NCI-5762
Study First Received: January 27, 2003
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00053170     History of Changes
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Vidarabine
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Breast Diseases
Skin Diseases
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 30, 2009