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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654030
• Other study ID #: CTN-0505
• Secondary ID: UKIRB 06-0716-F3
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2008
• Last updated: March 11, 2018
• Start date: October 2006
• Est. completion date: November 2009

Study information

• Verified date: March 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• 1650-G Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4

Locations

Country	Name	City	State
United States	Commonwealth Cancer Center	Danville	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Owensboro Medical Health System	Owensboro	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Edward Hirschowitz	Kentucky Lung Cancer Research Program

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks after vaccination