Clinical Trials /

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

NCT00095862

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CDR0000393552
  • SECONDARY ID: WRI-GEV-007
  • NCT ID: NCT00095862

Conditions

  • Breast Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DrugSynonymsArms
allogeneic GM-CSF-secreting breast cancer vaccine
recombinant interferon alfa
cyclophosphamide

Purpose

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.

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 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.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety, tolerability, and feasibility
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Suspended
Lead Sponsor:Wiseman Research Initiatives LLC

Trial Keywords

  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • unspecified adult solid tumor, protocol specific

Last Updated

December 17, 2013