CompletedPhase 2NCT00654030

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

StatusCompleted
PhasePhase 2
U.S. locations4
SponsorEdward Hirschowitz
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Edward Hirschowitz
Interventions being studied
Drug: 1650-G Vaccine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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