Lung Cancer Clinical Trial
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
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 vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
Full 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 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.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There are 4 Locations for this study
Danville Kentucky, 40422, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Owensboro Kentucky, 42303, United States
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