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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)

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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


- 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

- 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

PROJECTED ACCRUAL: A total of 117 patients (67 previously untreated and 50 previously
treated) will be accrued for this study.

Inclusion Criteria


- 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



- Over 18

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- 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


- 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

- Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases
are present)


- Not specified


- See Disease Characteristics

- Patients requiring surgery for tumor tissue procurement must meet the following

- 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


- 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

- 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


- 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


- 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


Biologic therapy

- More than 4 weeks since prior biologic therapy

- No prior gene therapy, including adenoviral-based therapy


- 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


- 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


- See Disease Characteristics

- More than 7 days since prior surgery and recovered


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free and overall survival

Safety Issue:


Principal Investigator

Angela Davies, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

August 2007

Related Keywords:

  • Lung Cancer
  • bronchoalveolar cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Lung Neoplasms