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Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00095862
Recruitment Status : Terminated
First Posted : November 9, 2004
Last Update Posted : February 5, 2018
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Unspecified Adult Solid Tumor, Protocol Specific Biological: allogeneic GM-CSF-secreting breast cancer vaccine Biological: recombinant interferon alfa Drug: cyclophosphamide Phase 1 Phase 2

Detailed Description:


  • Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors.
  • Determine the clinical response, time to progression, and survival of patients treated with this regimen.
  • Correlate clinical response with immunological response in patients treated with this regimen.

OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Safety, tolerability, and feasibility
  2. Clinical response
  3. Time to progression
  4. Survival
  5. Correlation of clinical response with immunological response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer meeting 1 of the following criteria:

    • Recurrent and/or metastatic lesions that are HER2/neu-positive or negative
    • Recurrent or progressive cancer of the lung, ovary, pancreas, prostate, bladder, or other primary site associated with HER2/neu-positive tumor by histochemistry
  • Bone-only metastatic breast cancer, cytologically confirmed malignant effusions, histologically confirmed marrow involvement, or other evaluable (but non-measurable) metastatic disease allowed
  • Failed prior first-line chemotherapy (e.g., anthracycline- or taxane-based therapy) with or without adjuvant chemotherapy or hormonal therapy
  • No curative or reliably effective palliative surgery, radiotherapy, or medical therapy available
  • Stable brain metastases allowed provided the following criteria are met*:

    • Previously treated
    • No concurrent requirement for corticosteroids
    • No radiological or clinical deterioration within the past 6 weeks NOTE: *Patients who had recent treatment with gamma knife or intensity-modulated radiotherapy for brain metastases are eligible provided there has been recovery from known or anticipated toxic effects
  • Patients with no HLA-A2 allele are eligible
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female or male

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 4 months


  • Absolute granulocyte count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 2 mg/dL
  • Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2 times ULN


  • BUN ≤ 30 mg/dL
  • Creatinine ≤ 2 mg/dL
  • ≤ 1 g protein on 24-hour urine collection OR
  • ≤ 1+ proteinuria on urinalysis


  • Hypertension controlled by agents (except beta-blockers) allowed


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No history of anaphylactic reaction to any known or unknown antigen
  • No history of clinical hypersensitivity to sargramostim (GM-CSF), interferon, yeast, beef, or to any components used in preparation of study vaccine
  • No clinical or laboratory features indicative of AIDS
  • No rheumatological, psychiatric, or other clinically progressive major medical problems requiring treatment
  • No other malignancy within the past 2 years


Biologic therapy

  • More than 3 weeks since prior biological therapy, including trastuzumab (Herceptin^®)
  • More than 3 weeks since prior immunotherapy
  • No concurrent immunotherapy


  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (8 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 3 weeks since prior hormonal therapy
  • No concurrent hormonal therapy
  • No concurrent systemic steroids

    • Concurrent inhalation steroids for respiratory hypersensitivity (e.g., triamcinolone nasal or pulmonary inhalers) allowed


  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • More than 3 weeks since prior major surgery with general anesthesia
  • No concurrent major surgery


  • Recovered from prior therapy
  • Patients receiving pamidronate, bisphosphonates, or other supportive measures must continue therapy during study participation
  • No concurrent anticoagulants
  • No concurrent beta-blockers for control of mild hypertension or other indications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095862

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United States, California
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Hollywood Presbyterian Medical Center
Los Angeles, California, United States, 90027-0902
Los Angeles, California, United States, 90057
Sponsors and Collaborators
Wiseman Research Initiatives LLC
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Study Chair: Charles L. Wiseman, MD, FACP
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Charles L. Wiseman, Wiseman Research Initiatives, LLC
ClinicalTrials.gov Identifier: NCT00095862    
Other Study ID Numbers: CDR0000393552
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: October 2011
Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer
male breast cancer
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiviral Agents
Anti-Infective Agents