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Lung Cancer Vaccine Plus Oral Dietary Supplement

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

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Lung Cancer Vaccine Plus Oral Dietary Supplement
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Biological: vaccine 1650-G
Other Name: Beta Glucan capsule
Study Arms  ICMJE Experimental: Vaccine plus oral beta glucan
Vaccine plus oral beta glucan
Intervention: Biological: vaccine 1650-G
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2013)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01829373
Other Study ID Numbers  ICMJE BG1006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Edward Hirschowitz, University of Kentucky
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Edward Hirschowitz
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Louisville
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP