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

This study is currently recruiting participants.

Verified by University of Kentucky, April 2008

First Received: April 2, 2008 Last Updated: April 4, 2008 History of Changes

Sponsors and Collaborators:	University of Kentucky Kentucky Lung Cancer Research Program
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00654030

Purpose

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	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: 1650-G Vaccine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:

Primary Outcome Measure: Immunological Response [ Time Frame: Evaluated for 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart	Drug: 1650-G Vaccine .6ml injection administered intradermally in the thigh at week 0 and week 4

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654030

Locations

United States, Kentucky
University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40536
Contact: Terry Foody, RN 859-257-9575 tfoody@email.uky.edu
Contact: Celia Love, BA 859-323-1109 clove1@email.uky.edu
Principal Investigator: Edward A Hirschowitz, MD
Sub-Investigator: John R Yannelli, PhD
University of Louisville Hospital	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jamie Day, RN 888-802-8149 jmluka01@louisville.edu
Contact: Celia Love, BA 859-323-1109 clove1@email.uky.edu
Principal Investigator: Goetz H Kloecker, MD, FACP
Sub-Investigator: Vivek R Sharma, MD, FACP
Sub-Investigator: Damian A Laber, MD, FACP
Sub-Investigator: Donald M Miller, MD, PhD
Owensboro Medical Health System	Recruiting
Owensboro, Kentucky, United States, 42303
Contact: Shawn Sams, RN 270-688-3691 ssams@omhs.org
Contact: Celia Love, BA 859-323-1109 clove1@email.uky.edu
Principal Investigator: Dattatraya S Prajapati, MD
Sub-Investigator: Jewraj G Maheshwari, MD
Sub-Investigator: Alan P Mullins, MD
Commonwealth Cancer Center	Recruiting
Danville, Kentucky, United States, 40422
Contact: Julie Jones, MT 859-236-2203 jjonesmt128@aol.com
Contact: Celia Love, BA 859-323-1109 clove1@email.uky.edu
Principal Investigator: Thomas R Baeker, MD

Sponsors and Collaborators

University of Kentucky

Kentucky Lung Cancer Research Program

Investigators

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

Publications:

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.

Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104. Review.

Responsible Party:	University of Kentucky ( Edward Alan Hirschowitz, MD )
Study ID Numbers:	CTN-0505, UKIRB 06-0716-F3R, ULIRB 065.07, CIRB 1079747
Study First Received:	April 2, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00654030 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Kentucky:

Lung Cancer Vaccine
Early Stage Lung Cancer
Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 09, 2009