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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

Primary Purpose

Breast Cancer, Gastric Cancer, Lung Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MVF-HER-2(628-647)-CRL 1005 vaccine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, adenocarcinoma of the stomach, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or recurrent solid tumor, especially the following: Breast Ovarian Non-small cell lung cancer Gastric adenocarcinoma No standard therapy available No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT less than 2 times upper limit of normal No hepatitis A, B, or C Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No serious cardiopulmonary disorder No congestive heart failure No symptomatic coronary artery disease No serious cardiac arrhythmia Pulmonary: No serious cardiopulmonary disorder No symptomatic chronic obstructive pulmonary disease Immunologic: Reactive to at least 1 of the following skin test antigens: Candida, mumps, Trichophyton, intermediate strength PPD, tetanus toxoid No concurrent disease requiring corticosteroids or other immunosuppressive drugs No autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, or vasculitic syndrome No prior anaphylactic response to other vaccine No hypersensitivity to MVF-HER-2(628-647) Other: No active HIV No active infection requiring antibiotic therapy No serious medical disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered No prior splenectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Dose #1

    Dose #2

    Dose #3

    Dose #4

    Dose #5

    Arm Description

    dose #1 administered

    dose #2 administered

    Dose #3 administered

    Dose #4 administered

    Administered dose #5

    Outcomes

    Primary Outcome Measures

    Determine the optimum biologic dose of MVF-HER-2 (628-647)-CRL 1005 vaccine that will induce snit-HER-2 antibody in patients with metastatic or recurrent cancer

    Secondary Outcome Measures

    Characterize the nature and severity of toxicity of this drug in these patients.
    Document any clinical responses to this drug in these patients.

    Full Information

    First Posted
    June 6, 2001
    Last Updated
    August 2, 2013
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00017537
    Brief Title
    Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
    Official Title
    Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2000 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer.
    Detailed Description
    OBJECTIVES: I. Determine the optimum biologic dose of MVF-HER-2(628-647)-CRL 1005 vaccine that will induce anti-HER-2 antibody in patients with metastatic or recurrent cancer. II. Characterize the nature and severity of toxicity of this drug in these patients. III. Document any clinical responses to this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive MVF-HER-2(628-647)-CRL 1005 vaccine intramuscularly on days 1 and 29. Cohorts of 5 patients receive escalating doses of MVF-HER-2(627-647)-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting toxicity. Patients are followed on days 43 and 57 and every 2 months for at least 1 year. PROJECTED ACCRUAL: Approximately 5-25 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
    Keywords
    stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, adenocarcinoma of the stomach, stage IV non-small cell lung cancer, unspecified adult solid tumor, protocol specific

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dose #1
    Arm Type
    Experimental
    Arm Description
    dose #1 administered
    Arm Title
    Dose #2
    Arm Type
    Experimental
    Arm Description
    dose #2 administered
    Arm Title
    Dose #3
    Arm Type
    Experimental
    Arm Description
    Dose #3 administered
    Arm Title
    Dose #4
    Arm Type
    Experimental
    Arm Description
    Dose #4 administered
    Arm Title
    Dose #5
    Arm Type
    Experimental
    Arm Description
    Administered dose #5
    Intervention Type
    Biological
    Intervention Name(s)
    MVF-HER-2(628-647)-CRL 1005 vaccine
    Primary Outcome Measure Information:
    Title
    Determine the optimum biologic dose of MVF-HER-2 (628-647)-CRL 1005 vaccine that will induce snit-HER-2 antibody in patients with metastatic or recurrent cancer
    Time Frame
    baseline to 1 year
    Secondary Outcome Measure Information:
    Title
    Characterize the nature and severity of toxicity of this drug in these patients.
    Time Frame
    baseline to 1 year
    Title
    Document any clinical responses to this drug in these patients.
    Time Frame
    baseline to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or recurrent solid tumor, especially the following: Breast Ovarian Non-small cell lung cancer Gastric adenocarcinoma No standard therapy available No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT less than 2 times upper limit of normal No hepatitis A, B, or C Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No serious cardiopulmonary disorder No congestive heart failure No symptomatic coronary artery disease No serious cardiac arrhythmia Pulmonary: No serious cardiopulmonary disorder No symptomatic chronic obstructive pulmonary disease Immunologic: Reactive to at least 1 of the following skin test antigens: Candida, mumps, Trichophyton, intermediate strength PPD, tetanus toxoid No concurrent disease requiring corticosteroids or other immunosuppressive drugs No autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, or vasculitic syndrome No prior anaphylactic response to other vaccine No hypersensitivity to MVF-HER-2(628-647) Other: No active HIV No active infection requiring antibiotic therapy No serious medical disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered No prior splenectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre L. Triozzi, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

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