Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied1650-G Vaccine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 9, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Edward Hirschowitz

Study sponsor

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

Explore related studies

How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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.

View original record ↗