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

NCT ID: NCT00654030

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1650-G Vaccine

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

Group Type: EXPERIMENTAL

1650-G Vaccine

Intervention Type: DRUG

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

Interventions

1650-G Vaccine

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

Intervention Type: DRUG

Other Intervention Names

1650-G Allogeneic Cellular Vaccine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kentucky Lung Cancer Research Program

OTHER

Sponsor Role: collaborator

Edward Hirschowitz

OTHER

Sponsor Role: lead

Responsible Party

Edward Hirschowitz

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edward A Hirschowitz, MD

Role: STUDY_CHAIR

University of Kentucky

John R Yannelli, PhD

Role: STUDY_CHAIR

University of Kentucky

Goetz H Kloecker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Thomas R Baeker, MD

Role: PRINCIPAL_INVESTIGATOR

Commonwealth Cancer Center

Dattatraya S Prajapati, MD

Role: PRINCIPAL_INVESTIGATOR

Owensboro Medical Health System

Locations

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15254048 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 17409835 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21150468 (View on PubMed)

Other Identifiers

UKIRB 06-0716-F3R

Identifier Type: OTHER

Identifier Source: secondary_id

ULIRB 065.07

Identifier Type: OTHER

Identifier Source: secondary_id

CIRB 1079747

Identifier Type: OTHER

Identifier Source: secondary_id

CTN-0505

Identifier Type: -

Identifier Source: org_study_id