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

NCT00074295 | Terminated Phase 2 DMC

• 3 other identifiers: CDR0000343797U10CA032102S0310
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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 in treating patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.

Conditions

Lung Cancer

Keywords

bronchoalveolar cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (5)

• Progression-free and overall survival

• Response rate

• Toxicity

• Functional status

• Correlation of systemic biologic activity with clinical outcome

Study Arms (1)

treatment

EXPERIMENTAL

GVAX lung cancer vaccine

Biological: GVAX lung cancer vaccine

Interventions

GVAX lung cancer vaccine BIOLOGICAL

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

Also known as: CG8123

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Angela Davies, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Raja Mudad, MD, FACP

  Tulane University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: March 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 24, 2012

Record last verified: 2012-07