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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
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Edward Hirschowitz, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: vaccine 1650-G Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lung Cancer Immunotherapy With Vaccine 1650-G and Yeast Derived β-Glucan
Study Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Vaccine plus oral beta glucan
Vaccine plus oral beta glucan
Biological: vaccine 1650-G
Other Name: Beta Glucan capsule




Primary Outcome Measures :
  1. Immunologic response to vaccine [ Time Frame: 12 months ]
    Increase in number of peripheral blood T cells recognizing cancer antigens



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829373


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Edward Hirschowitz
University of Louisville
Investigators
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Principal Investigator: Edward Hirschowitz, MD University of Kentucky
Principal Investigator: John Yannelli, PhD University of Kentucky

Publications:
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Responsible Party: Edward Hirschowitz, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01829373     History of Changes
Other Study ID Numbers: BG1006
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Edward Hirschowitz, University of Kentucky:
lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs