Status:
COMPLETED
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Lead Sponsor:
Edward Hirschowitz
Collaborating Sponsors:
Kentucky Lung Cancer Research Program
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells. The Purpose of this study is to evaluate the effects of a lung cancer va...
Detailed Description
The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly a...
Eligibility Criteria
Inclusion
- Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
- Surgically resected at least 4 weeks ago but not more than 6 months ago
- Bronchoalveolar carcinomas allowed
- Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
- No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
- ECOG performance status of 0 to 2
- Adequate organ and marrow function defined as follows:
- Hemoglobin ≥9.0 gm/dL
- Bilirubin \< 2.5 x upper limit of normal
- AST \<2.5 x upper limit of normal
- ALT \<2.5 x upper limit of normal
- Creatinine \<3 mg/dL
- Women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16.
Exclusion
- Cardiovascular disease defined as:
- New York Heart Association Class III or IV (Section 19.2) congestive heart failure
- hemodynamically significant valvular heart disease
- myocardial infarction within the last six months
- active angina pectoris
- uncontrolled ventricular arrhythmias
- stroke within one year
- known cerebrovascular disease
- History of HIV, infectious hepatitis, or chronic immunosuppressive disease
- concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
- History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
- Female patients must not be pregnant or breastfeeding.
- History of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00654030
Start Date
October 1 2006
End Date
November 1 2009
Last Update
April 9 2018
Active Locations (4)
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1
Commonwealth Cancer Center
Danville, Kentucky, United States, 40422
2
University of Kentucky
Lexington, Kentucky, United States, 40536
3
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
4
Owensboro Medical Health System
Owensboro, Kentucky, United States, 42303