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

Phase 2

Completed

Brief 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.

Detailed Description: The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
1650-G Vaccine	1650-G Vaccine	Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Responding to the Vaccine	16 weeks after vaccination	The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (\>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (\> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.

Secondary Outcome Measures

Name	Time	Method

Locations (4): 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
Commonwealth Cancer Center
🇺🇸Danville, Kentucky, United States