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S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GVAX lung cancer vaccine
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring bronchoalveolar cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis* of 1 of the following by radiological features and clinical presentation: Bronchoalveolar carcinoma (BAC) Diffuse or ground glass appearance Adenocarcinoma with bronchoalveolar features BAC with focal invasion NOTE: *Histological confirmation (excluding fine needle aspiration or bronchial brushings or washings) is required after the tumor tissue has been procured and the vaccine has been produced Selected stage IIIB (due to malignant pleural effusion) OR stage IV disease Measurable or nonmeasurable disease (e.g., diffuse infiltrative process) by CT scan of the chest both before and after tumor tissue procurement for vaccine Not a candidate for curative resection Tumor accessible for tissue procurement via thoracentesis or a surgical procedure If a pleural effusion is the source of tumor tissue, at least 600 mL of fluid must be available for vaccine manufacture Resection of brain metastases may be used for vaccine processing Surgery must be done after study entry Asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastases allowed provided the patient is neurologically stable No active or impending spinal cord compression or evidence of pericardial tamponade PATIENT CHARACTERISTICS: Age Over 18 Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 CD4 count greater than 200/mm^3 No bleeding disorder Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases are present) Renal Not specified Cardiovascular See Disease Characteristics Patients requiring surgery for tumor tissue procurement must meet the following criteria: Pulmonary artery systolic pressure < 40 mm Hg by echocardiogram* LVEF > 40% No symptomatic congestive heart failure No thrombolic disorder No unstable angina pectoris No cardiac arrhythmia NOTE: *Not needed if patient has no tricuspid regurgitation Pulmonary No pulmonary hypertension No significant baseline hypoxia (i.e., O_2 saturation less than 90% OR requires greater than 2 L/min of supplemental O_2 via nasal cannula) by an oxygen saturation test No postobstructive pneumonia Patients requiring thoracoscopic surgery or thoracotomy for tumor tissue procurement must meet the following criteria: Alveolar partial pressure of CO_2 < 45 mm Hg Predicted postresection FEV_1 ≥ 1.0 L DLCO > 50% of predicted Immunologic No active immune or autoimmune disease No systemic lupus erythematosus No sarcoiditis No rheumatoid arthritis No glomerulonephritis No vasculitis No serious infection No hypersensitivity to any of the following: Sargramostim (GM-CSF) Pentastarch Gentamicin Human serum albumin Dimethyl sulfoxide Porcine trypsin Fetal bovine serum Recombinant benzonase Other components of the vaccine or CG6444 adenoviral vector used in this study Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No poor nutritional status No psychiatric illness or social situation that would preclude study compliance or increase operative risk No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy No prior gene therapy, including adenoviral-based therapy Chemotherapy More than 4 weeks since prior chemotherapy No prior regional chemotherapy administered through the pulmonary artery (if resection of the tumor in the treated lobe is planned) Endocrine therapy More than 14 days since prior systemic corticosteroids No concurrent steroids Radiotherapy See Disease Characteistics More than 4 weeks since prior radiotherapy Disease must be outside the areas of prior radiotherapy OR clear progression at prior irradiated sites must be documented No prior radiotherapy to the tumor mass targeted for resection Surgery See Disease Characteristics More than 7 days since prior surgery and recovered Other More than 2 weeks since prior epidermal growth factor receptor inhibitors No other concurrent nonprotocol-specified treatment No concurrent immunosuppressants No concurrent chronic anticoagulation therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment

    Arm Description

    GVAX lung cancer vaccine

    Outcomes

    Primary Outcome Measures

    Progression-free and overall survival
    Response rate
    Toxicity
    Functional status
    Correlation of systemic biologic activity with clinical outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2003
    Last Updated
    July 20, 2012
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00074295
    Brief Title
    S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
    Official Title
    Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    closed due to lack of availability of vaccine
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.
    Detailed Description
    OBJECTIVES: Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine. Determine the response rate (confirmed and unconfirmed and complete and partial) in patients treated with this vaccine. Determine the frequency and severity of toxic effects of this vaccine in these patients. Determine the functional status of patients treated with this vaccine. Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic cytokine responses) with clinical outcome in patients treated with this vaccine. OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma (BAC) (yes vs no) and pattern of BAC (diffuse vs nodular). After successful vaccine manufacturing from tumor tissue procured, patients receive GVAX lung cancer vaccine intradermally (ID) (6-7 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 9, 13, and 21. Patients are followed at 4 weeks, every 8 weeks for 1 year, and then every 12 weeks for 2 years. PROJECTED ACCRUAL: A total of 117 patients (67 previously untreated and 50 previously treated) 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
    Lung Cancer
    Keywords
    bronchoalveolar cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment
    Arm Type
    Experimental
    Arm Description
    GVAX lung cancer vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    GVAX lung cancer vaccine
    Other Intervention Name(s)
    CG8123
    Intervention Description
    6-7 injections per week in rotating locations for five weeks
    Primary Outcome Measure Information:
    Title
    Progression-free and overall survival
    Title
    Response rate
    Title
    Toxicity
    Title
    Functional status
    Title
    Correlation of systemic biologic activity with clinical outcome

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis* of 1 of the following by radiological features and clinical presentation: Bronchoalveolar carcinoma (BAC) Diffuse or ground glass appearance Adenocarcinoma with bronchoalveolar features BAC with focal invasion NOTE: *Histological confirmation (excluding fine needle aspiration or bronchial brushings or washings) is required after the tumor tissue has been procured and the vaccine has been produced Selected stage IIIB (due to malignant pleural effusion) OR stage IV disease Measurable or nonmeasurable disease (e.g., diffuse infiltrative process) by CT scan of the chest both before and after tumor tissue procurement for vaccine Not a candidate for curative resection Tumor accessible for tissue procurement via thoracentesis or a surgical procedure If a pleural effusion is the source of tumor tissue, at least 600 mL of fluid must be available for vaccine manufacture Resection of brain metastases may be used for vaccine processing Surgery must be done after study entry Asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastases allowed provided the patient is neurologically stable No active or impending spinal cord compression or evidence of pericardial tamponade PATIENT CHARACTERISTICS: Age Over 18 Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 CD4 count greater than 200/mm^3 No bleeding disorder Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases are present) Renal Not specified Cardiovascular See Disease Characteristics Patients requiring surgery for tumor tissue procurement must meet the following criteria: Pulmonary artery systolic pressure < 40 mm Hg by echocardiogram* LVEF > 40% No symptomatic congestive heart failure No thrombolic disorder No unstable angina pectoris No cardiac arrhythmia NOTE: *Not needed if patient has no tricuspid regurgitation Pulmonary No pulmonary hypertension No significant baseline hypoxia (i.e., O_2 saturation less than 90% OR requires greater than 2 L/min of supplemental O_2 via nasal cannula) by an oxygen saturation test No postobstructive pneumonia Patients requiring thoracoscopic surgery or thoracotomy for tumor tissue procurement must meet the following criteria: Alveolar partial pressure of CO_2 < 45 mm Hg Predicted postresection FEV_1 ≥ 1.0 L DLCO > 50% of predicted Immunologic No active immune or autoimmune disease No systemic lupus erythematosus No sarcoiditis No rheumatoid arthritis No glomerulonephritis No vasculitis No serious infection No hypersensitivity to any of the following: Sargramostim (GM-CSF) Pentastarch Gentamicin Human serum albumin Dimethyl sulfoxide Porcine trypsin Fetal bovine serum Recombinant benzonase Other components of the vaccine or CG6444 adenoviral vector used in this study Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No poor nutritional status No psychiatric illness or social situation that would preclude study compliance or increase operative risk No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy No prior gene therapy, including adenoviral-based therapy Chemotherapy More than 4 weeks since prior chemotherapy No prior regional chemotherapy administered through the pulmonary artery (if resection of the tumor in the treated lobe is planned) Endocrine therapy More than 14 days since prior systemic corticosteroids No concurrent steroids Radiotherapy See Disease Characteistics More than 4 weeks since prior radiotherapy Disease must be outside the areas of prior radiotherapy OR clear progression at prior irradiated sites must be documented No prior radiotherapy to the tumor mass targeted for resection Surgery See Disease Characteristics More than 7 days since prior surgery and recovered Other More than 2 weeks since prior epidermal growth factor receptor inhibitors No other concurrent nonprotocol-specified treatment No concurrent immunosuppressants No concurrent chronic anticoagulation therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela Davies, MD
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Raja Mudad, MD, FACP
    Organizational Affiliation
    Tulane University Health Sciences Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer

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