Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
GVAX lung cancer vaccine
Lung Diseases+4
+ Lung Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives