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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: 1650-G Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1650-G Vaccine<br>Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study. | Drug: 1650-G Vaccine<br>* .6ml injection administered intradermally in the thigh at week 0 and week 4<br>* Other names: 1650-G Allogeneic Cellular Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Responding to the Vaccine | 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. | 16 weeks after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer