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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edward Hirschowitz; University of Kentucky
• Collaborator: Kentucky Lung Cancer Research Program
• Treatments: Vaccines

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.