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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Outcome Measure: Immunological Response; Antigen Specific Reactions Will be Measured by IFN-ELISPOT. The ELISPOT is a Quantitative Readout of Number of T Cells That React to Specific Antigenic Stimulus.

Outcome Description:

The endpoint is immunologic response measured by IFN-ELISPOT. Increases above pre-vaccine levels (& controls) can be assessed statistically by ANOVA. Percent patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine) as well as magnitude of responses (relative ELISPOT measures) will be compared to results obtained using DC/1650 vaccine. The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.

Outcome Time Frame:

Evaluated for 52 weeks

Safety Issue:


Principal Investigator

Edward A Hirschowitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kentucky


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

November 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer Vaccine
  • Early Stage Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Louisville Hospital Louisville, Kentucky  40202
Owensboro Medical Health System Owensboro, Kentucky  42303
University of Kentucky Lexington, Kentucky  40536-0098
Commonwealth Cancer Center Danville, Kentucky  40422