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

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 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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; 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.

Enrollment:	12
Study Start Date:	October 2006
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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
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

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, 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.

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:	Edward Hirschowitz, Associate Professor of Medicine, University of Kentucky
ClinicalTrials.gov Identifier:	NCT00654030 History of Changes
Other Study ID Numbers:	CTN-0505, UKIRB 06-0716-F3R, ULIRB 065.07, CIRB 1079747
Study First Received:	April 2, 2008
Results First Received:	August 17, 2011
Last Updated:	April 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Kentucky:

Lung Cancer Vaccine
Early Stage Lung Cancer
Lung Cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013