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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: GVAX lung cancer vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>GVAX lung cancer vaccine | Biological: GVAX lung cancer vaccine<br>* 6-7 injections per week in rotating locations for five weeks<br>* Other names: CG8123;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free and overall survival |  |  | 
| Response rate |  |  | 
| Toxicity |  |  | 
| Functional status |  |  | 
| Correlation of systemic biologic activity with clinical outcome |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoalveolar cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer