Status:
TERMINATED
S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed 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 res...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00074295
Start Date
March 1 2004
End Date
August 1 2007
Last Update
July 24 2012
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