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

SWOG Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Biological: GVAX lung cancer vaccine

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00074295

S0310 (Other Identifier)

CDR0000343797

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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