Lung Cancer Vaccine Plus Oral Dietary Supplement

• ClinicalTrials.gov Identifier: NCT01829373
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: April 11, 2013
• Sponsor: Edward Hirschowitz
• Collaborator: University of Louisville
• Information provided by (Responsible Party): Edward Hirschowitz, University of Kentucky

Tracking Information

• First Submitted Date: April 8, 2013
• First Posted Date: April 11, 2013
• Last Update Posted Date: April 11, 2013
• Study Start Date: October 2011
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2013)

Immunologic response to vaccine [ Time Frame: 12 months ]

Increase in number of peripheral blood T cells recognizing cancer antigens

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lung Cancer Vaccine Plus Oral Dietary Supplement
• Official Title: Lung Cancer Immunotherapy With Vaccine 1650-G and Yeast Derived β-Glucan
• Brief Summary: This study tests the ability of the allogeneic cellular vaccine 1650-G vaccine to enhance immune recognition of tumor cells in patients with lung cancer. The vaccine is combined with an oral medication called beta glucan, an over the counter oral dietary supplement that may also stimulate the immune system in ways that helps the body eradicate cancer cells and reduce risk of recurrent cancer. The primary purpose of this study is to measure the changes in the number of immune cells that might help lower risk of cancer recurrence. The investigators do not yet know if the vaccine is effective in fighting cancer and will not know at the end of this study whether this has been of benefit.
• Detailed Description: Open-label pilot (Phase II) study to assess the immunologic activity of a cellular vaccine composed of killed allogeneic tumor cells (1650-G) and GM-CSF in patients with stage I-IIIA NSCLC after definitive therapy. (Surgery, Surgery plus Radiation Therapy, or Surgery, Radiation Therapy plus Adjuvant Chemotherapy).
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

Biological: vaccine 1650-G

Other Name: Beta Glucan capsule

Study Arms

Experimental: Vaccine plus oral beta glucan

Vaccine plus oral beta glucan

Intervention: Biological: vaccine 1650-G

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, Hidalgo GE, Yannelli JR. Immunization of NSCLC patients with antigen-pulsed immature autologous dendritic cells. Lung Cancer. 2007 Sep;57(3):365-72. doi: 10.1016/j.lungcan.2007.04.002. Epub 2007 May 16.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 10, 2013): 5
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically proven, surgically resected stage I-IIIA NSCLC (Bronchoalveolar carcinomas are eligible).
• Must have read, voiced understanding of and signed an informed consent document.
• At least 21 years old
• At least 4 weeks but no more than 12 months post surgical resection.
• At least 4 weeks since completion of chemotherapy or radiation therapy (adjuvant)
• No evidence of disease following definitive initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of accrual.
• ECOG performance status of 0 to 2 (Section 19.1)
• Adequate organ and marrow function defined as follows:
• Hemoglobin ≥9.0 gm/dL
• Absolute neutrophil count (ANC) ≥1,500/mcl
• Platelet count ≥ 75,000/mcl
• AST <2.5 x upper limit of normal
• ALT <2.5 x upper limit of normal
• Creatinine Clearance (CCr) >50 ml/min
• Female patients must not be pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test and agree to use acceptable birth control until the "analysis for immunologic response" 16 weeks after the second vaccination. Study doctor will discuss acceptable methods of contraception with patients.

Exclusion Criteria:

• Patients must not have not have no active residual or progressive lung cancer (Stable Disease)
• History of other malignancies unless they have had curative treatment completed greater than (≥) five years prior to enrollment or one of the following; appropriately managed Carcinoma in situ, basal cell carcinoma of the skin or non-metastatic squamous cell carcinoma of the skin.
• Patients must not be chronically immunosuppressed.
• Patients with HIV and other immunosuppressive disorders and patient who chronically use immunosuppressive medications are excluded. Patients should not be taking immuno-suppressive steroids for at least 4 weeks prior to enrollment
• Individuals with conditions that might require shorter courses of immunosuppressive oral medications (e.g. steroids) during the initial 16 weeks following immunization are excluded.
• Patients should not have taken or plan to take other immunologically active agents (eg flu vaccines) for a twelve week period, beginning 2 weeks prior to first dose of beta-glucan and two weeks following last dose of beta glucan.
• Patients must not have a known history of infectious hepatitis.
• Because of the unknown effects of this treatment on the fetus pregnant females, and childbearing females and males not willing to use contraception are not eligible.
• Patients must not have cardiovascular disease defined as:
• New York Heart Association Class III or IV 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
• Patients may not have received any other investigational agents or participated in any investigational drug study within 4 weeks preceding initiation of study treatment.
• No known allergies or history of allergic reactions to any colony stimulating factor (GCSF, GMCSF)
• No known intolerance to yeast derive β-glucan

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01829373
• Other Study ID Numbers: BG1006
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Edward Hirschowitz, University of Kentucky
• Original Responsible Party: Same as current
• Current Study Sponsor: Edward Hirschowitz
• Original Study Sponsor: Same as current
• Collaborators: University of Louisville

Investigators

• Principal Investigator: Edward Hirschowitz, MD; University of Kentucky
• Principal Investigator: John Yannelli, PhD; University of Kentucky

• PRS Account: University of Kentucky
• Verification Date: April 2013