Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	SWOG-S0310 S0310, NCT00074295

Objectives

1. Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine.
2. Determine the response rate (confirmed and unconfirmed and complete and partial) in patients treated with this vaccine.
3. Determine the frequency and severity of toxic effects of this vaccine in these patients.
4. Determine the functional status of patients treated with this vaccine.
5. Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic cytokine responses) with clinical outcome in patients treated with this vaccine.

Entry 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

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

Patient Characteristics:

Age

• Over 18

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• CD4 count greater than 200/mm³
• 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., O₂ saturation less than 90% OR requires greater than 2 L/min of supplemental O₂ 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 CO₂ < 45 mm Hg
  • Predicted postresection FEV₁ ≥ 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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Angela Davies, MD, Study coordinator		Ph: 916-734-3771
Raja Mudad, MD, FACP, Study coordinator		Ph: 504-988-2967; 800-588-5300 Email: muda001@mailhost.tcs.tulane.edu

Registry Information
Official Title		Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Trial Start Date		2004-03-01
Registered in ClinicalTrials.gov		NCT00074295
Date Submitted to PDQ		2003-11-04
Information Last Verified		2005-08-17
NCI Grant/Contract Number		U10-CA32102

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