Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Apr 9, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Edward Hirschowitz
- Interventions being studied
- Drug: 1650-G Vaccine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Commonwealth Cancer CenterDanville, Kentucky
- University of KentuckyLexington, Kentucky
- University of Louisville HospitalLouisville, Kentucky
- Owensboro Medical Health SystemOwensboro, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 9, 2018. Always confirm current availability with the study team.