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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: 1650-G 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Danville, Kentucky, United States, 40422
      • Commonwealth Cancer Center
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Medical Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 1650-G Allogeneic Cellular Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Edward Hirschowitz
• Collaborators: 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

Publications and helpful links

General 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. doi: 10.1200/JCO.2004.01.074.
• Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: April 2, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: March 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Lung Cancer; Early Stage Lung Cancer; Lung Cancer Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• 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)