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Docetaxel With or Without Vaccine Therapy and GM-CSF in Treating Patients With Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217750
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a gene-modified virus may help the body build an immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of white blood cells found in bone marrow or peripheral blood. GM-CSF may also help the vaccine work better. It is not yet known whether giving docetaxel together with vaccine therapy and GM-CSF is more effective than docetaxel alone in treating metastatic breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with vaccine therapy and GM-CSF works compared to docetaxel alone in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: falimarev
Drug: inalimarev
Drug: sargramostim
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Sargramostim Granulocyte-macrophage colony-stimulating factor PANVAC-V
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC™ -V (Vaccinia) and PANVAC™-F (Fowlpox) in Adults With Metastatic Breast Cancer

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

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • CD8+T cell responses [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2005
Estimated Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive vaccinia-CEA-MUC-1-TRICOM vaccine subcutaneously (SC) once and sargramostim (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel IV over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
Drug: docetaxel
given IV
Drug: falimarev
given subcutaneously
Drug: inalimarev
given subcutaneously
Drug: sargramostim
given subcutaneously
Arm II: Experimental
Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and GM-CSF as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Drug: docetaxel
given IV

Detailed Description:

OBJECTIVES:

Primary

  • Compare the progression-free survival of patients with metastatic breast cancer treated with docetaxel with vs without vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim (GM-CSF).

Secondary

  • Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, pilot study. HER-2 positive patients are stratified according to concurrent trastuzumab (Herceptin®) therapy (yes or no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive vaccinia-CEA-MUC-1-TRICOM vaccine subcutaneously (SC) once and sargramostim (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel IV over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
  • Arm II: Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and GM-CSF as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

After completion of study treatment, patients are followed annually for 15 years.

PROJECTED ACCRUAL: A total of 48 patients (24 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease
  • Radiographic evidence of measurable disease on CT scan or X-ray, or evidence of evaluable disease on bone scan that is consistent with metastasis
  • HLA-A2 phenotype known

    • At least 12 patients in each treatment arm must be HLA-A2 positive
  • HER2/neu status known

    • Must have progressive or recurrent disease after prior trastuzumab (Herceptin®) therapy if disease is HER2/neu-positive by fluorescence in situ hybridization or immunohistochemistry (3+)
  • No clinically active brain metastases
  • Hormone receptor status:

    • Estrogen-receptor (ER) status known
    • Patients with ER-positive tumor must have failed prior primary hormonal therapy unless clinically indicated (i.e., in patients with visceral disease or symptomatic bone disease where upfront chemotherapy is warranted)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:

    • SGOT and SGPT < 1.5 times upper limit of normal (ULN)
    • SGOT and SGPT ≤ 2 times ULN AND alkaline phosphatase < 2.5 times ULN
  • Hepatitis B and C negative

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min*
  • Proteinuria < 1,000 mg by 24-hour urine collection* NOTE: *Unless due to nonrenal causes

Cardiovascular

  • No New York Heart Association class II-IV cardiac disease
  • No clinically significant cardiomyopathy requiring treatment
  • No cardiac complications including any of the following:

    • Recent myocardial infarction
    • Cerebrovascular accident within the past year
    • Unstable or uncontrolled angina

Gastrointestinal

  • No inflammatory bowel disease
  • No Crohn's disease
  • No ulcerative colitis
  • No active diverticulitis

Immunologic

  • HIV negative
  • No history of allergy or untoward reaction to prior vaccinia virus vaccination
  • No history of allergy or hypersensitivity reaction to eggs or egg products
  • No active autoimmune disease requiring treatment OR history of autoimmune disease that may be stimulated by vaccine therapy
  • No altered immune function, including any of the following conditions:

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

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after completion of study treatment
  • Endocrine disease, including thyroid disease, adrenal disease, and vitiligo, that is controlled by replacement therapy allowed
  • Must appear clinically stable, in the opinion of the investigator, to complete the full 3-month course of vaccination
  • No active seizures within the past year or clinically active brain metastasis
  • No close household contact (i.e., shares housing or has close physical contact) with the following individuals within 2 weeks after vaccinia vaccination:

    • Individuals with a history of or active eczema or other eczematoid skin disorders
    • Individuals 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 3 years of age and under
    • Immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV-positive individuals
  • No other serious medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior vaccinia-CEA-MUC-1-TRICOM or fowlpox-CEA-MUC-1-TRICOM vaccines
  • No other concurrent anticancer immunotherapy

Chemotherapy

  • At least 12 months since prior adjuvant docetaxel

    • No prior docetaxel for metastatic disease
  • At least 3-4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or carboplatin)
  • Unlimited prior chemotherapy regimens allowed
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • Unlimited prior hormonal therapy allowed
  • Patients who have progressed on trastuzumab (Herceptin®) may continue to receive therapy unless discontinued at the time of study entry (i.e., cannot be resumed while on study treatment)
  • No concurrent systemic steroids except physiologic doses for systemic steroid replacement OR local (topical, nasal, or inhaled) steroid use
  • No concurrent steroid eye drops
  • No concurrent anticancer hormonal therapy

Radiotherapy

  • No concurrent anticancer radiotherapy

Surgery

  • No prior splenectomy
  • No concurrent major surgery

Other

  • Recovered from all prior therapy
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217750

Locations
United States, Maryland
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        
Sponsors and Collaborators
Investigators
Principal Investigator: James Gulley, MD, PhD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Web site for additional information  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000442407, NCI-05-C-0229, NCI-6977
Study First Received: September 20, 2005
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00217750  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Docetaxel
Skin Diseases
Breast Neoplasms, Male
Vaccinia
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009