Suspended

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

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What is being tested

GVAX lung cancer vaccine

Biological
Who is being recruted

Lung Diseases
+4

+ Lung Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual 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.

Official TitlePhase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) 
NCT00074295
Principal SponsorSWOG Cancer Research Network
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
19 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
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.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
GVAX lung cancer vaccine

6-7 injections per week in rotating locations for five weeks
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

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