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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00654030
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : May 20, 2013
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Kentucky Lung Cancer Research Program
Information provided by (Responsible Party):
Edward Hirschowitz, University of Kentucky

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: 1650-G Vaccine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : October 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1650-G Vaccine
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
 Drug: 1650-G Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4
Other Name: 1650-G Allogeneic Cellular Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Responding to the Vaccine [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654030


Locations
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United States, Kentucky
Commonwealth Cancer Center
Danville, Kentucky, United States, 40422
University of Kentucky
Lexington, Kentucky, United States, 40536
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Owensboro Medical Health System
Owensboro, Kentucky, United States, 42303
Sponsors and Collaborators
Edward Hirschowitz
Kentucky Lung Cancer Research Program
Investigators
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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
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Edward Hirschowitz, Associate Professor of Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT00654030    
Other Study ID Numbers: CTN-0505
UKIRB 06-0716-F3R ( Other Identifier: University of Kentucky )
ULIRB 065.07 ( Other Identifier: University of Louisville )
CIRB 1079747 ( Other Identifier: Commonwealth Cancer Center IRB )
First Posted: April 7, 2008    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: April 9, 2018
Last Verified: March 2018
Keywords provided by Edward Hirschowitz, University of Kentucky:
Lung Cancer Vaccine
Early Stage Lung Cancer
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs