The main purpose of this research study is to determine if a vaccine made from a patient’s lung cancer tumor cells will be effective in making the cancer shrink or disappear. The vaccine will be given by itself to some patients, while other patients will get the vaccine with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells. Additionally, the study will collect information on vaccine safety, both with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms (e.g., shortness of breath).

Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment, patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including active follow up, is approximately two years. After this, patients will be followed-up yearly for a total of 15 years.

Condition	Treatment or Intervention	Phase
Lung Cancer Carcinoma, Non-Small-Cell Lung	Vaccine: CG8123  Drug: Cyclophosphamide	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 18 years or older
• Suspicious diagnosis of or histologically- confirmed stage IIIB or IV non small-cell lung cancer
• Accessible and adequate tumor source for vaccine production.
• Tumor source for vaccine production must be accessible by a minor surgical procedure performed under local or regional anesthesia (e.g. lymph node or soft tissue mass or malignant pleural effusion)
• Measurable disease to evaluate following tumor procurement
• Limited metastatic tumor burden
• Life expectancy at least 4 months
• ECOG Performance Status 0 - 1

Exclusion Criteria:

• Active and/or untreated brain metastases
• Active or impending spinal cord compression
• Active auto-immune disease or treatment with immunosuppressants
• Decompensated congestive heart failure or recent significant cardiac event
• Coexisting malignancies
• Significant or uncontrolled medical problems or laboratory abnormalities that might increase the risk of surgical complications or vaccine treatment
• Previous treatment with gene therapy (including any adenoviral-based therapy)

Cell Genesys, Inc. GVAX Lung Cancer Clinical Trial Line      1.866.542.8509 
Cell Genesys, Inc. GVAX Lung Cancer Clinical Trial Line      1.516.679.4928 

California
      University of California, Los Angeles Medical Center, Los Angeles,  California,  90095,  United States; Recruiting
      University of California, San Francisco/Mt. Zion, San Francisco,  California,  94115,  United States; Recruiting
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States; Recruiting
Florida
      US Oncology, Orlando,  Florida,  34761,  United States; Recruiting
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      US Oncology, Albany,  New York,  12208,  United States; Recruiting
Oregon
      Providence Portland Medical Center, Portland,  Oregon,  97213,  United States; Recruiting
Pennsylvania
      University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232,  United States; Recruiting
Texas
      US Oncology/MCMRC, Dallas,  Texas,  75246,  United States; Recruiting
      US Oncology, Tyler,  Texas,  75702,  United States; Recruiting
Washington
      US Oncology, Spokane,  Washington,  99218,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States; Recruiting

Study ID Numbers:  D-0031
Record last reviewed:  August 2004
Record first received:  August 11, 2004
ClinicalTrials.gov Identifier:  NCT00089726
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10