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

NCT00654030 | Completed Phase 2 Results DMC

• 4 other identifiers: CTN-0505UKIRB 06-0716-F3RULIRB 065.07CIRB 1079747
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Lung Cancer Vaccine; Early Stage Lung Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1650-G Vaccine

EXPERIMENTAL

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

Drug: 1650-G Vaccine

Interventions

1650-G Vaccine DRUG

.6ml injection administered intradermally in the thigh at week 0 and week 4

Also known as: 1650-G Allogeneic Cellular Vaccine

1650-G Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Hirschowitz: lead
• Kentucky Lung Cancer Research Program: collaborator

Study Sites (4)

Commonwealth Cancer Center

Danville, Kentucky, 40422, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Owensboro Medical Health System

Owensboro, Kentucky, 42303, United States

Location

Related 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. doi: 10.1200/JCO.2004.01.074.

  PMID: 15254048 BACKGROUND

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

  PMID: 17409835 BACKGROUND

• 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.

  PMID: 21150468 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Edward Hirschowitz
• Organization: University of Kentucky

eahirs2@uky.edu

859-323-5045

Study Officials

• Edward A Hirschowitz, MD

  University of Kentucky

  STUDY CHAIR

• John R Yannelli, PhD

  University of Kentucky

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 9, 2018
• Results First Posted: May 20, 2013

Record last verified: 2018-03

Locations

US (4)