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

This study has been completed.
Sponsor:
Collaborator:
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Edward Hirschowitz, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00654030
First received: April 2, 2008
Last updated: April 8, 2013
Last verified: April 2013
History of Changes

April 2, 2008
April 8, 2013
October 2006
November 2009   (final data collection date for primary 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. [ Time Frame: Evaluated for 52 weeks ] [ Designated as safety issue: No ]
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.
Primary Outcome Measure: Immunological Response [ Time Frame: Evaluated for 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00654030 on ClinicalTrials.gov Archive Site
Not Provided
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Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: 1650-G Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4
Other Name: 1650-G Allogeneic Cellular Vaccine
Experimental: 1650-G Vaccine
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
Intervention: Drug: 1650-G Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00654030
CTN-0505, UKIRB 06-0716-F3R, ULIRB 065.07, CIRB 1079747
Yes
Edward Hirschowitz, University of Kentucky
University of Kentucky
Kentucky Lung Cancer Research Program
Study Chair: Edward A Hirschowitz, MD University of Kentucky
Study Chair: John R Yannelli, PhD University of Kentucky
Principal Investigator: Goetz H Kloecker, MD University of Louisville
Principal Investigator: Thomas R Baeker, MD Commonwealth Cancer Center
Principal Investigator: Dattatraya S Prajapati, MD Owensboro Medical Health System
University of Kentucky
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP