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Status:

TERMINATED

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

Lead Sponsor:

Wiseman Research Initiatives LLC

Conditions:

Breast Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

PHASE2

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 ...

Detailed Description

OBJECTIVES: * 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 ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Female or male
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 4 months
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 2 mg/dL
  • Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2 times ULN
  • Renal
  • BUN ≤ 30 mg/dL
  • Creatinine ≤ 2 mg/dL
  • ≤ 1 g protein on 24-hour urine collection OR
  • ≤ 1+ proteinuria on urinalysis
  • Cardiovascular
  • Hypertension controlled by agents (except beta-blockers) allowed
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 3 weeks since prior biological therapy, including trastuzumab (Herceptin\^®)
  • More than 3 weeks since prior immunotherapy
  • No concurrent immunotherapy
  • Chemotherapy
  • 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
  • Radiotherapy
  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • More than 3 weeks since prior major surgery with general anesthesia
  • No concurrent major surgery
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00095862

    Start Date

    November 1 2004

    Last Update

    February 5 2018

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, United States, 91204

    2

    Hollywood Presbyterian Medical Center

    Los Angeles, California, United States, 90027-0902

    3

    Los Angeles, California, United States, 90057