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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00654030

Run by

Edward Hirschowitz

People needed

12

Starts

2006-10-01

Expected to finish

2009-11-01

Last updated by the study team

2018-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify if…

• 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.

Where it is running

• Commonwealth Cancer Center — Danville, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Owensboro Medical Health System — Owensboro, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.