Status:
COMPLETED
A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Cell Genesys
Conditions:
Lung Cancer
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00089726
Start Date
March 1 2003
End Date
January 1 2006
Last Update
December 24 2007
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