Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edward Hirschowitz
With
Kentucky Lung Cancer Research Program
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 after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Cardiovascular disease defined as:
* New York Heart Association Class III or IV (Section 19.2) congestive heart failure
