Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Vaccines

Immunologic Factors

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

.6ml injection administered intradermally in the thigh at week 0 and week 4

1650-G Vaccine

Edward A Hirschowitz, MD

John R Yannelli, PhD

Goetz H Kloecker, MD

Thomas R Baeker, MD

Dattatraya S Prajapati, MD

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.

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.

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

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

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.

Kentucky Lung Cancer Research Program

Edward Hirschowitz

Associate Professor of Medicine

Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart

1650-G Arm

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Edward Hirschowitz

2 immunizations of 1650-G given 4 weeks apart

1650-G ARM

Number of Participants Responding to the Vaccine

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer	NCT00654030	Non-Small Cell ...	1650-G Vaccine	18 Years -	University of Kentucky
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer	NCT00654030	Non-Small Cell ...	1650-G Vaccine	18 Years -	University of Kentucky

Spots Global Cancer Trial Database for lung cancer vaccine