Last updated on December 2006

Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB
    non-small cell lung cancer (NSCLC) according to the Revised International System for
    Staging Lung Cancer
    Primary surgical resection of lung cancer greater than or equal to 4 weeks and less
    than or equal to 3 years prior to the Day 0 visit
    No evidence of disease by standard diagnostic tests
    Chest X-ray and physical examination showing no active disease
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to
    1,500 cells/mm3
    Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than
    or equal to 125,000 cells/mm3
    Adequate renal function (defined as serum creatinine <1.5 times the upper limit of
    normal for females and males)
    Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of
    normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times
    the upper limit of normal)
    Ability to understand and willingness to sign an IRB-approved written consent prior
    to study enrollment
    Female patients must be greater than or equal to 60 years of age, or greater than or
    equal to 5 years amenorrhea or surgically sterile
    Male patients who are capable of fathering a child and whose partners are capable of
    having a child must agree to use adequate contraception for 6 months after enrollment
    (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal
    ring or IUD)
    Absolute CD4+ cell count of >200 cells/mm3
    Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB
    non-small cell lung cancer (NSCLC) according to the Revised International System for
    Staging Lung Cancer
    Primary surgical resection of lung cancer greater than or equal to 4 weeks and less
    than or equal to 3 years prior to the Day 0 visit
    No evidence of disease by standard diagnostic tests
    Chest X-ray and physical examination showing no active disease
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to
    1,500 cells/mm3
    Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than
    or equal to 125,000 cells/mm3
    Adequate renal function (defined as serum creatinine <1.5 times the upper limit of
    normal for females and males)
    Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of
    normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times
    the upper limit of normal)
    Ability to understand and willingness to sign an IRB-approved written consent prior
    to study enrollment
    Female patients must be greater than or equal to 60 years of age, or greater than or
    equal to 5 years amenorrhea or surgically sterile
    Male patients who are capable of fathering a child and whose partners are capable of
    having a child must agree to use adequate contraception for 6 months after enrollment
    (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal
    ring or IUD)
    Absolute CD4+ cell count of >200 cells/mm3
    Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB
    non-small cell lung cancer (NSCLC) according to the Revised International System for
    Staging Lung Cancer
    Primary surgical resection of lung cancer greater than or equal to 4 weeks and less
    than or equal to 3 years prior to the Day 0 visit
    No evidence of disease by standard diagnostic tests
    Chest X-ray and physical examination showing no active disease
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to
    1,500 cells/mm3
    Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than
    or equal to 125,000 cells/mm3
    Adequate renal function (defined as serum creatinine <1.5 times the upper limit of
    normal for females and males)
    Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of
    normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times
    the upper limit of normal)
    Ability to understand and willingness to sign an IRB-approved written consent prior
    to study enrollment
    Female patients must be greater than or equal to 60 years of age, or greater than or
    equal to 5 years amenorrhea or surgically sterile
    Male patients who are capable of fathering a child and whose partners are capable of
    having a child must agree to use adequate contraception for 6 months after enrollment
    (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal
    ring or IUD)
    Absolute CD4+ cell count of >200 cells/mm3
    Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB
    non-small cell lung cancer (NSCLC) according to the Revised International System for
    Staging Lung Cancer
    Primary surgical resection of lung cancer greater than or equal to 4 weeks and less
    than or equal to 3 years prior to the Day 0 visit
    No evidence of disease by standard diagnostic tests
    Chest X-ray and physical examination showing no active disease
    Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to
    1,500 cells/mm3
    Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than
    or equal to 125,000 cells/mm3
    Adequate renal function (defined as serum creatinine <1.5 times the upper limit of
    normal for females and males)
    Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of
    normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times
    the upper limit of normal)
    Ability to understand and willingness to sign an IRB-approved written consent prior
    to study enrollment
    Female patients must be greater than or equal to 60 years of age, or greater than or
    equal to 5 years amenorrhea or surgically sterile
    Male patients who are capable of fathering a child and whose partners are capable of
    having a child must agree to use adequate contraception for 6 months after enrollment
    (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal
    ring or IUD)
    Absolute CD4+ cell count of >200 cells/mm3

You may not be eligible for this study if the following are true:

  • Received pre- or post-operative radiotherapy
    Received prior biologic, immunologic, or gene therapy for cancer
    Received an investigational drug (new chemical entity) within three months of study
    entry
    Received antibiotics within 2 weeks of Day 0 visit
    Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4
    weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing
    glucocorticosteroids is acceptable)
    History of active autoimmune diseases such as, but not limited to, systemic lupus
    erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or
    inflammatory bowel disease
    History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
    History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
    Received any commercial vaccine within 2 weeks of Day 0 visit
    Received a major organ allograft
    Current or previous diagnosis of paraneoplastic syndrome
    Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less
    than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse
    oximetry less than or equal to 92% at the time of study entry
    Known to be HIV positive
    Results of virology screening indicate positive serology for HCV (hepatitis C virus)
    and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is
    allowed.
    History of other malignancies at other sites, except effectively treated non-melanoma
    kin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an
    effectively treated malignancy that has been in remission for greater than 5 years
    and is highly likely to have been cured
    Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal,
    genitourinary or other illness) considered as unwarranted high risk for
    investigational new drug treatment
    Patient is lactating
    Staging classification of TX or NX or MX
    Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit
    Received pre- or post-operative radiotherapy
    Received prior biologic, immunologic, or gene therapy for cancer
    Received an investigational drug (new chemical entity) within three months of study
    entry
    Received antibiotics within 2 weeks of Day 0 visit
    Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4
    weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing
    glucocorticosteroids is acceptable)
    History of active autoimmune diseases such as, but not limited to, systemic lupus
    erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or
    inflammatory bowel disease
    History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
    History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
    Received any commercial vaccine within 2 weeks of Day 0 visit
    Received a major organ allograft
    Current or previous diagnosis of paraneoplastic syndrome
    Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less
    than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse
    oximetry less than or equal to 92% at the time of study entry
    Known to be HIV positive
    Results of virology screening indicate positive serology for HCV (hepatitis C virus)
    and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is
    allowed.
    History of other malignancies at other sites, except effectively treated non-melanoma
    kin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an
    effectively treated malignancy that has been in remission for greater than 5 years
    and is highly likely to have been cured
    Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal,
    genitourinary or other illness) considered as unwarranted high risk for
    investigational new drug treatment
    Patient is lactating
    Staging classification of TX or NX or MX
    Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit
    Received pre- or post-operative radiotherapy
    Received prior biologic, immunologic, or gene therapy for cancer
    Received an investigational drug (new chemical entity) within three months of study
    entry
    Received antibiotics within 2 weeks of Day 0 visit
    Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4
    weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing
    glucocorticosteroids is acceptable)
    History of active autoimmune diseases such as, but not limited to, systemic lupus
    erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or
    inflammatory bowel disease
    History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
    History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
    Received any commercial vaccine within 2 weeks of Day 0 visit
    Received a major organ allograft
    Current or previous diagnosis of paraneoplastic syndrome
    Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less
    than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse
    oximetry less than or equal to 92% at the time of study entry
    Known to be HIV positive
    Results of virology screening indicate positive serology for HCV (hepatitis C virus)
    and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is
    allowed.
    History of other malignancies at other sites, except effectively treated non-melanoma
    kin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an
    effectively treated malignancy that has been in remission for greater than 5 years
    and is highly likely to have been cured
    Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal,
    genitourinary or other illness) considered as unwarranted high risk for
    investigational new drug treatment
    Patient is lactating
    Staging classification of TX or NX or MX
    Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit
    Received pre- or post-operative radiotherapy
    Received prior biologic, immunologic, or gene therapy for cancer
    Received an investigational drug (new chemical entity) within three months of study
    entry
    Received antibiotics within 2 weeks of Day 0 visit
    Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4
    weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing
    glucocorticosteroids is acceptable)
    History of active autoimmune diseases such as, but not limited to, systemic lupus
    erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or
    inflammatory bowel disease
    History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
    History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
    Received any commercial vaccine within 2 weeks of Day 0 visit
    Received a major organ allograft
    Current or previous diagnosis of paraneoplastic syndrome
    Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less
    than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse
    oximetry less than or equal to 92% at the time of study entry
    Known to be HIV positive
    Results of virology screening indicate positive serology for HCV (hepatitis C virus)
    and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is
    allowed.
    History of other malignancies at other sites, except effectively treated non-melanoma
    kin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an
    effectively treated malignancy that has been in remission for greater than 5 years
    and is highly likely to have been cured
    Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal,
    genitourinary or other illness) considered as unwarranted high risk for
    investigational new drug treatment
    Patient is lactating
    Staging classification of TX or NX or MX
    Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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