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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
1650-G Vaccine
Sponsored by
Edward Hirschowitz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Commonwealth Cancer Center
  • University of Kentucky
  • University of Louisville Hospital
  • Owensboro Medical Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1650-G Vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2008
Last Updated
March 11, 2018
Sponsor
Edward Hirschowitz
Collaborators
Kentucky Lung Cancer Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT00654030
Brief Title
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Official Title
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Hirschowitz
Collaborators
Kentucky Lung Cancer Research Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1650-G Vaccine
Arm Type
Experimental
Arm Description
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
Intervention Type
Drug
Intervention Name(s)
1650-G Vaccine
Other Intervention Name(s)
1650-G Allogeneic Cellular Vaccine
Intervention Description
.6ml injection administered intradermally in the thigh at week 0 and week 4
Primary Outcome Measure Information:
Title
Number of Participants Responding to the Vaccine
Description
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.
Time Frame
16 weeks after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward A Hirschowitz, MD
Organizational Affiliation
University of Kentucky
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John R Yannelli, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Goetz H Kloecker, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas R Baeker, MD
Organizational Affiliation
Commonwealth Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dattatraya S Prajapati, MD
Organizational Affiliation
Owensboro Medical Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Cancer Center
City
Danville
State/Province
Kentucky
ZIP/Postal Code
40422
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Owensboro Medical Health System
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15254048
Citation
Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.
Results Reference
background
PubMed Identifier
17409835
Citation
Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104.
Results Reference
background
PubMed Identifier
21150468
Citation
Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, Damron K, Love C, Yannelli JR. Pilot study of 1650-G: a simplified cellular vaccine for lung cancer. J Thorac Oncol. 2011 Jan;6(1):169-73. doi: 10.1097/JTO.0b013e3181fb5c22.
Results Reference
result

Learn more about this trial

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

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